iWounds News 2 – February 2020

February 2020 | Issue 02 Michael Edmonds: Following ilegx to prevent amputation

Thomas Serena:

Wound care cooperation

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Page 6

Wound care specialists can improve microcirculation by maximising “the overall vascular health of patients”

It is the refrain William Ennis (University of Illinois, Chicago, USA) hears continually: “I cannot do anything about the microcirculation!” His swift response, however, at the annual meeting of the American College of Wound Healing and Tissue Repair (ACWHTR 2019; 11–12 October, Chicago, USA) was that “you can do a lot by treating the patient”.

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nnis was speaking during a presentation entitled “Microcirculation: What, How, Why?”, in which he explained how imaging techniques can change what wound care specialists do, and offered an in-depth analysis of the variety of available devices.

He laid out some of the possibilities, pondering “whichever device you decide to use, when you come up with a positive finding, then what?”. Ennis, a professor of surgery at the University of Illinois at Chicago, USA, and chief medical officer at wound care centre provider Healogics (Jacksonville, Florida, USA), added: “Can you change the microcirculation? Well, you can assess it before and after a procedure, before and after the use of energy-based modalities, or you could use an angiosome-based revascularisation procedure and then measure success or failure.

“I would argue the other thing we can do is maximise the overall vascular health of the patient. We can really work on getting patients to stop smoking and make sure to screen patients for sleep apnoea, as well as making sure someone has been studied with an echo before we

Multicentre trial shows superiority of PICO singleuse NPWT over traditional delivery system SMITH+NEPHEW HAS announced the publication of results from a new randomised controlled trial (RCT), demonstrating that the use of the PICO single-use negative pressure wound therapy (sNPWT) system significantly reduces wound area, depth and volume, compared with traditional negative pressure wound therapy (tNPWT) in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs).

According to a statement, chronic wounds affect six million people in the USA alone, with increasing numbers anticipated in growing elderly and diabetic populations.

use compression bandaging and move a large amount of extravascular fluid centrally, to avoid tipping someone into congestive heart failure. We can work on the management of their hypertension, as that has an impact on the microcirculation. Also, William Ennis we can analyse and try to lower central venous pressure for the same reasons.”

Ennis issued a caution on device selection. “What we are not going to do is tell you which of these devices to get,” he told delegates, before highlighting that there were a number of questions circulating in the wound village at ACWHTR regarding this question. “I would rather ask you what question it is that you are trying to solve. For example, are you looking for a device that

Moreover, one study showed that in a single year, chronic wounds cost US$9.7 billion. These wounds can be managed with tNPWT, but it is complex to use and also limits patient mobility.

The randomised, controlled, multicentre study was conducted at 16 centres in the USA and two centres in Canada, comparing the efficacy and safety of PICO sNPWT with tNPWT in the management of patients with lower extremity ulcers of a longer-than-four-week duration over 12 weeks. In total, 164 patients were randomised to receive either PICO sNPWT or tNPWT. A greater average reduction in wound area of 39.1%, depth of 32.5% and volume of 91.1%, versus tNPWT, was observed with PICO sNPWT. In addition, there was a 51% relative increase in the number of patients achieving wound closure at 12 weeks with PICO sNPWT versus tNPWT.

Continued on page 2

Dressing changes were also less frequent with PICO sNPWT compared to tNPWT, with 6.8 fewer changes and 3.4 days longer wear time reported. Overall satisfaction was greater with PICO sNPWT as well, and fewer patients had adverse events with PICO than with tNPWT. “I decided to use PICO sNPWT to treat a diabetic foot ulcer after achieving excellent results using the therapy on skin flaps and full thickness skin grafts,” said Rosemary Hill, wound ostomy nurse at Lions Gate Hospital, Vancouver, Canada.

“By introducing PICO as an early intervention for lower extremity ulcers, we have been able to help kickstart wound healing and ultimately improve the quality of life for patients, who experience a faster and more predictable healing trajectory, as well as being mobile and able to resume treatment at home,” she added.

Una Adderley: Xxxxxxx Xxxxxxx:

Profile

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Updated international guidelines highlight new “damage cascade” for why pressure ulcers develop As part of newly published international guidelines on the prevention and treatment of pressure ulcers, it has been revealed that these wounds occur, primarily, due to the deformation and distortion of cells and tissues. Previously, it was understood that ischaemia— caused by the distortion of the vasculature—was the chief reason for the development of pressure ulcers but, as Amit Gefen (Tel Aviv University, Tel Aviv, Israel) has underlined, the availability of new scientific methods has offered a different perspective on the “damage cascade” of this type of wound.

GEFEN PRESENTED a new approach to the problem of pressure ulcers at the Wounds UK annual conference (4–6 November 2019, Harrogate, UK) ahead of the guidelines’ release. Jointly published by the European Pressure Ulcer Advisory Panel (EPUAP), US-based National Pressure Ulcer Advisory Panel (NPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA), these recommendations are said to “reflect global scientific knowledge” and provide “evidence-based” guidance for both prevention and treatment.

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February 2020 | Issue 02

Microcirculation

Wound care specialists can improve microcirculation by maximising “the overall vascular health of patients” Continued from page 1

is a tool for the rapid screening of the overall arterial system? Then maybe you could use one of the devices to measure the microcirculation on the plantar surface of the foot where pigmentation is not an impact, and that could act as a surrogate for the overall macrovascular status. This information could add to a patient’s history and physical exam and, perhaps, help you triage the patient for a vascular consultation.”

Other devices can add further information to the overall picture of wound healing, such as the SurroSense Rx sensory system insoles (Orpyx), which monitor both the pressure and temperature of conditions.

“So think about the questions you are trying solve,” Ennis said. “That will help you to better understand what you want and which devices you need. It may end up, unfortunately, that you need more than one device.

The type of device you need will also be dictated by the type of wounds you see in your clinic. For example, some clinics focus on diabetic foot ulcers (DFUs) only, while others see wounds of all aetiologies. Ultimately, this should lead to adequate macrovascular status with the end result being adequate delivery of oxygen and the formation of ATP. In the past, our group has used biopsy methods such as NMR spectroscopy to assess the ATP levels of wounds before and after procedures, but these tests are invasive, tedious and expensive.”

There is a “disconnect” between the testing and understanding of macro- and microcirculation in the wound care space, Ennis said. “What I want to encourage people to do is to take a step back when you evaluate these types of imaging systems and think about

What I want to encourage people to do is to take a step back when you evaluate these types of imaging systems.”

the macro level first. When we start to think about the microcirculation however, we need to think about the vascular system as a whole going all the way to the level of the heart, as well as pulmonary hypertension, right ventricular failure, vena cava obstruction, lymphatic disease, and of course the arterial side of circulation”.

Ennis continued on the theme of complex systems theory when he stated that if you drink a cup of coffee in the morning prior to your microvascular testing, you would have increased peripheral vascular resistance and this could alter your results. One cigarette can result in 60 minutes of vasospasm and also produce erroneous testing when assessing the microcirculation.

Ennis then drew delegates back to the live surgical presentation from earlier in the conference, performed by his colleague Martin Borhani (University of Illinois, Chicago, USA). In this case, an endarterectomy procedure had been performed, resulting in increased blood flow to the calcaneus; on the live surgical case, a very robust granulation tissue was seen throughout the wound bed of the patient’s heel. A microvascular study was performed and demonstrated what appeared to be a very good blood flow to the granulation tissue.

“Sometimes a patient like this,” Ennis explained, “will receive a skin graft and within 72 hours good pigmentation and engraftment is present, only for necrosis to begin 5–6 days after the procedure. By day 10, the graft might have been completely sloughed off.”

Ennis continued: “One of the possible reasons for this delayed skin graft failure could be the patient’s resumption of cigarette smoking in the immediate postoperative period, as these new, fragile vessels are susceptible to vasoconstriction from nicotine. Let us say, however, that you have a totally compliant patient who did not do any of the things that could harm the graft, and who states that they have kept their legs elevated.

They then say: ‘I thought you guys told me I was ready for a skin graft; why did it not take?’

“By utilising devices that measure both the quantity and the quality of flow to the microcirculation, we might be able to gain an insight into when patients are ready for skin grafting and when the highest likelihood is that engraftment will proceed in an orderly fashion. It turns out that when providers have tremendous experience in this area, they are usually adept at determining skin graft take versus failure rates just by looking at the wound bed. That knowledge, however, is not present in many providers who only see a few wounds in any given year. The hope is that these devices will democratise knowledge and experience.”

Now, the field of wound care requires a piece of technology that steps into this void. “It does not mean that you do not need the experts, but the technology can try to level the playing field by providing adjunctive assistance in wound healing decision-making.”

News in brief

The latest stories from the wound care world

n NATIONAL WOUND CARE STRATEGY: One of several wound care leaders involved in raising awarenss about the importance of evidencebased research, Leanne Atkin has stressed that “we have to aim for meta-analyses, systematic reviews and randomised controlled trials”. According to Atkin, there is currently limited evidence in the wound care space, and the number of high quality trials is described as “very, very small”, because this type of study on wounds can be very difficult to control and expensive to conduct.

For more on this story go to page 4 n PROMISE 1 TRIAL: Discussing the results of an early feasibility trial, Daniel Clair explains how no-option patients with critical limb ischaemia, who would have previously received a “deadend angioplasty” in an effort to promote healing, now have another chance. The percutaneous deep vein arterialisation system LimFlow has emerged as an option, and was investigated in PROMISE I, a prospective, single-arm study launched in 2017.

For more on this story go to page 8 n DIABETIC FOOT GUIDELINES: The International Working Group on the Diabetic Foot has presented their own review of the literature and suggested new best practice guidelines, which are explored further here by Raju Ahluwalia, Chris Manu and Ines L Reichert. They explain how a series of clinical questions were devised to review the medical-scientific literature and formulate an updated series of recommendations.

For more on this story go to page 16

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February 2020 | Issue 02

Wound care

National Wound Care Strategy aiming for “excellence” across lower limb and surgical workstreams “Our aim is to establish the underlying economic and clinical case for change, identify what needs to happen and describe how we make that change happen,” argued Una Adderley, director of the National Wound Care Strategy Programme, who was presenting on the current progress of the strategy at the Wounds UK annual conference (4–6 November 2019, Harrogate, UK). The programme was initiated in September 2018, and Adderley reported that a lot of work has been done in the last 12 months.

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nderlining how the problem of chronic wounds is growing, with current estimates showing that the spend on wound care is roughly similar to that of obesity, Adderley, Jacky Edwards (Manchester, UK) and Leanne Atkin (University of Huddersfield, Huddersfield, UK) spoke about the size of the challenge facing the nursing community and how changes are being implemented.

secondary care, because we all need to be informed of what is going on”.

“We also need point-of-care data capture technologies and a national specification so that everyone is collecting that data in the same way.

Otherwise, how do we know what is happening?” asked the presenter, who also drew attention to different workstreams under the umbrella of the National Wound Care Strategy.

Climbing the mountain

Lower limb wound care

During her talk at Wounds UK, Adderley emphasised that the purpose of the programme, established at its inception, was to “scope the development of a strategy that focuses on improving care for pressure ulcers, lower limb ulcers and surgical wounds”. In total, lower limb wounds, surgical wounds and pressure ulcers represent over half of the wounds that are treated in the UK, with those on the lower limb accounting for 40%.

In terms of underpinning principles at the foundation of the strategy, it has been recognised that wound care should not be viewed as a separate clinical issue. Instead, Adderley spoke about the importance of collaboration with partners in other disciplines, “as it is no good just being focused on tissue viability”.

Adderley continued: “We really want to aim for excellence; although we may not succeed in every care, my argument is that we still have to aim for the best or we will never get to a point where the level of care is good enough.”

Focusing on what has been achieved so far, the programme director revealed that draft levels of evidence for new products in the wound care arena are in development. “I found it quite shocking that the evidence-level for wound care products is roughly the same as a health app,” said Adderley, who opined that “you need the appropriate study design to actually test claims made, and that is not happening at the moment”.

Furthermore, the case is being made for a guideline on venous leg ulceration, while principles are also being developed for data collection. Adderley stated that data and information for wound care should be derived from national datasets, and “this information should be available across primary care, community care and

As co-chair of the lower limb workstream under the National Wound Care Strategy, Leanne Atkin drew attention—in a presentation at Wounds UK—to recommendations that are being developed for the care of lower limb wounds, as well as the current obstacles to improved treatment, assessment and referral for patients.

Speaking about the importance of evidence-based research, Atkin stressed that “we have to aim for meta-analyses, systematic reviews and randomised controlled trials”; there is currently limited evidence in the wound care space, while the number of high quality trials is described as “very, very small”. As the presenter pointed out to attendees, this type of study on wounds can be very difficult to control and expensive to conduct, as well as taking a significant amount of time.

Although leg wrap systems for the management of venous ulcers are not being recommended at this juncture, due to a lack of sufficient evidence, Atkin confirmed that the results of the VenUS IV trial have shown that compression hosiery kits are equally effective as compression bandaging for the healing of wounds.

Moreover, the benefits of endovenous ablation were also acknowledged during the presentation, as found by the results of the EVRA and ESCHAR trials. Atkin highlighted that by ablating the veins as well as using compression, you can heal a patient 30 days quicker which, along with the findings of the ESCHAR study that demonstrated a 30% reduction in the risk of recurrence, clearly supports the case for ablation.

Looking at next steps, Atkin commented: “What I challenge you to

Una Adderley

Leanne Atkin

do is to stop seeing the venous leg ulcer as a simple wound: it is not. You would not go into your garden and chop off the dandelion’s head numerous times; instead, you have to think about the roots, which, with venous leg ulcers, are found in the venous system.”

Atkin also stated that “as soon as the wound has occurred, 20mmHg of compression should be applied, and the patient should be referred for further

What I challenge you to do is to stop seeing the venous leg ulcer as a simple wound.” assessment”. The importance of an early intervention cannot be understated, according to the presenter, as this allows for a more accurate diagnosis and facilitates the escalation of patients to therapies such as compression within two weeks of initial presentation.

The problem of surgical wound dehiscence

In her presentation at Wounds UK, chair of the surgical wounds workstream Jacky Edwards forwarded: “One of the things that we are really keen to communicate is that while we are pretty good at looking at surgical site infections (SSIs), for which there is also a really good NICE guideline, it is not always the reason for dehiscence.” Reviewing some of the other factors involved, Edwards

discussed how there can be technical issues in how the wound is actually closed, what level of tissue is being closed and the mechanism used, as well as other variables.

“Often, the method of surgical closure can fail,” said Edwards, who explained that this happens because “there is too much pressure, while sutures can break through into tissues due to being placed too close to the edge of the incision or put under too much tension”. Other problems, like mechanical stress, are usually caused by the method of closure and can provoke other complications, such as oedema around the wound.

Considering the challenge at hand, Edwards commented that “understanding the size of this problem” is crucial, especially with the number of surgical operations performed in the NHS rising each year.

As part of the surgical wounds workstream, efforts are being made to highlight the red flags, which includes aspects of surgical wound dehiscence that cause concern and how this information is fed back to the original surgeon.

Edwards also accentuated the need for a rigorous and consistent classification system across all platforms, alongside the National Wound Care Strategy’s data work stream, which will “help guide staff and ensure patients get back to surgeons when necessary”.

Edwards concluded: “One of the key things we also identified is that there is not a validated surgical risk assessment tool, which is not for us as part of the National Wound Care Strategy for us to fix. However, I do believe this is a research problem which must be looked at for us all to understand the risks.”

Issue 02 | February 2020

Updated international guidelines highlight new “damage cascade” for why pressure ulcers develop Continued from page 1

Speaking on the severity of pressure ulcers, and the impact they can have, Gefen stated: “You may know that pressure ulcers commonly affect the elderly, but this is not always the case. They can impact a wide number of different populations, ranging in age from the very young to the elderly, as well as people in an active phase of their life for whom a wound like this would be a disaster.

“From a health economics perspective, this is a scary situation, especially when you extrapolate our current predicament into the future. Developing countries are getting older and chronic diseases, which are a risk factor for pressure ulcers, are spreading, particularly diabetes. This is not going to get better on its own, so we need to do something today.”

Reviewing why pressure ulcers develop

While it is accepted that all pressure ulcers are caused by forces, which means that “whenever we are interacting with any kind of support surface, our tissues are distorted and deformed”, Gefen reminded attendees at Wounds UK that this deformation can happen when forces are not only static, but also dynamic.

“We have developed, over many years, several different models and systems to try and understand why these wounds happen,” Gefen explained. “Some work has been done on human subjects, mainly employing medical imaging modalities, and by performing an MRI scan in an unloaded configuration, when your buttocks are just about touching the chair, and fully loaded, when you are in full contact, we can actually quantify the extent of tissue deformation.”

However, in order to understand the impact of exposure to this kind of deformation at a cellular level, a substitute to a human subject is required. According to Gefen, science has now progressed sufficiently so that, instead of using animal models, living pieces of tissue can be cultured in a so-called “tissue engineering” process; once developed, these samples can be utilised to determine the effects of cellular deformation and the viability of individual cells when exposed to sustained distortions.

Based on the results of experiments using cultured tissue, Gefen commented that “even with normal levels of oxygen or glucose, cells still die because of their exposure to sustained deformation”. This supports the idea that ischaemia, or a lack of adequate blood flow, is not a primary factor in the cell death mechanism, which has significant implications for how pressure ulcers should be treated and—if possible—prevented in the future.

Providing a further explanation as to how pressure ulcers really develop, as part of a newly understood damage cascade, Gefen said: “It happens because cells are structures, which have a certain capacity in supporting or bearing mechanical loads. Once that capacity has been exceeded, in terms of both the magnitude of the load and exposure time, the cell structure starts to fail.

“When deformation is sustained, skeleton structures in the cell (the cytoskeleton) start to fail, and as they are the supporting structure to the plasma membrane, which regulates all ions and molecules that may enter or leave the cell body, the transport capacity of the cell

Pressure ulcers is now severely compromised.

“Once the integrity of the plasma membrane has been damaged, the cell will die very soon. At this point, the skeleton, which is the supporting structure for all of our vital organs, will begin to break down, and the same phenomenon happens at the scale of a cell.

This is fundamentally different than the now outdated aetiological description of pressure ulcers or injuries, which has existed in the literature for many centuries.

If the direct deformation damage happens within minutes, ischaemic damage takes a much longer time to develop.”

Inflammation was also highlighted by Gefen as a critically important factor which must be considered, because it is a component of a “snowball effect” that leads to pressure ulcers. After the first cells have died, due to exposure to sustained deformations, the inflammatory response is triggered.

Once the body has sent white blood cells to the site of damage, the permeability of the vascular structures around this site also increases (to allow the immune cells to leave the vasculature). Consequently, blood vessels become leaky and oedema begins to develop.

In addition, the secretion of fluid from these vessels prompts the tissue to expand, but this often cannot happen because the soft tissues are trapped between the bone and the support surface.

The inability of the tissue to expand in volume leads to an increase in interstitial pressure, causing further cell and tissue deformation and distortion. This means that even if the body part is offloaded after the initial deformation-injury, the damage will continue while that inflammation persists.

“We are looking at multiple processes that contribute to the damage, each of which worsens the situation in its own characteristic way and time point,” argued Gefen. “According to our new theory, cell and tissue damage accumulates due to three primary contributors, which are deformation, inflammation and ischaemia; the latter joins in last, typically, when the vasculature

We are looking at multiple processes that contribute to the damage, each of which worsens the situation in its own characteristic way.”

Amit Gefen

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is distorted too (typically due to the oedema), affecting blood flow.”

Complications and potential solutions

Despite the much clearer understanding offered by the guidelines, as to how pressure ulcers develop, Gefen asserted that it is still incredibly difficult to predict, on a patient-to-patient basis, when a pressure ulcer will occur. He said: “If you think about each of these three components, all will contribute to the damage cascade at their own onset point and rate. If someone has a blood flow or cardiac issue, for example, they would be more susceptible to the ischaemic damage.”

The goal, as Gefen suggests, should be to postpone what can be a “horrific cascade” for these wounds to a point in the future that is “as far away as possible”.

In terms of a first step, Gefen emphasised that the overall level of deformation must be lowered, which is very different to increasing blood flow alone, as this (potential ischaemia) is just one derivative of the overall deformation state.

Looking ahead to the future of pressure ulcer care, the need for special medical technologies that lower a patient’s exposure to sustained tissue deformations, such as prophylactic dressings or positional overlays, was accentuated, as devices of this kind could potentially offer an effective primary prophylaxis.

“These technologies and products, however,” as Gefen pointed out, “must be evaluated now according to a completely different protocol than what we used to follow when we looked at blood flow by itself”.

Gefen concluded: “With the bioengineering analysis methodologies and tools now available to us, we can review and revisit designs of medical devices to understand what we are possibly doing wrong and think about what we can do better. There are new technologies for instance which, instead of trying to offload and thereby concentrating the mechanical loads into very narrow regions, spread the loads as wide as possible. This achieves much better results, as demonstrated by computer models which give a quantitative and standardised measure of the exposure of tissues to loads, both at the skin surface and internally.”

Finally, he added: “We are now learning to control the environment of cells as well, so we can ensure that they function in an optimal way. An injury is always the product of a race between the body’s ability to repair and the progress of the damage in cells and then tissues. If we can help cells to repair themselves and their tissue micro-environment, we can introduce novel and ground-breaking methods to prevent pressure ulcers from becoming worse.”

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February 2020 | Issue 02

Wound research

US wound care experts lead project to develop new FDA-approved endpoints for clinical research

social isolation and depression that can be impactful.

Following the collection of data, the next step was to analyse this information and relevant literature. Driver said: “We created four teams of physical therapists, podiatrists, wound care doctors and nurses. We also had a team of 40 researchers across the USA that entered into one of these teams based on their experience and A new initiative supported by both the Association for the Advancement of Wound Care evaluated the evidence based on FDA regulations.”

(AAWC) and the Wound Healing Society (WHS)—the “Wound Care Expert/FDA-Clinical Based on the 146 papers that fulfilled FDA Endpoint Project” (WEF-CEP)—will take an updated list of primary endpoints for wound requirements and were reviewed, supportive pain was care trials to the US Food and Drug Administration (FDA), as revealed at the Symposium of revealed to be an important endpoint in wound healing, Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA). as well as time to heal, physical function/ambulation and, once again, amputation reduction. All ickie Driver (Brown University School of and researchers, including members of endpoints were looked at as they related Medicine, Providence, USA), one of many both the AAWC and WHS, over four to the data, before an Institutional Review clinicians who volunteered as part of the different time periods between January Board (IRB)-approved survey of patients project, began: “Five years ago we approached the FDA, 2015 and October 2015. “This is the list was conducted, receiving 451 responses. because we realised that in the field of wound care, the of the top endpoints that were important Turning her focus to the results of only endpoint which is recognised in clinical practice or to clinicians for clinical practice and what this survey, Driver commented: “What a clinical trial is complete wound closure.” matters to them every single day when is interesting here is the age of these “As a clinician, I am judged based on whether or treating patients,” said Driver, explaining patients. We are obligated to these patients not I close a patient’s wound. I would like to be judged the findings of the survey. for 20–40 years once they have a wound: on how well I am practicing medicine and preventing The list, which was divided into it is not the end of their life. For this amputations, but we have become very siloed into clinical practice and patient-centred reason, it is critical that we develop public thinking we should close every wound tomorrow.” outcomes, ranged from percentage area Vickie Driver policy that actually supports and allows us Due to the limitations that current regulations impose reduction (PAR) in four to eight weeks— to get payment for therapies that matter, on the development of new medicine and therapies for described by Driver as an important “predictor of so they are covered and we do not have to put the wound healing, especially for patients with a myriad complete closure”—to amputation reduction. Other top burden on the patient to pay for these things.” of other complications, the WEF-CEP project was endpoints included the reduction of infection, bioburden, Summarising the key points of the project, Driver launched. According to Driver, the FDA stipulated recurrence and pain, as well as social factors such as concluded: “What I want to point out here is that that additional endpoints would have to be planned, endpoints which mattered to clinicians and the industry presented and evaluated using “FDA qualified criteria” mattered to patients. Fortunately, we are on the same for new clinical outcomes. As a result, Driver et al page, but this had to be done to prove that: not only for were required to analyse data with a four-point Likert the FDA, but for us. This is the list of primary endpoints response format, considering factors such as reliability, that we will take to the FDA that have tools to measure clinical construct validity and capacity to detect change. them, because if you add endpoints, there must be a way Following advice from the FDA, researchers with the to measure them that the FDA and Centres for Medicare WEF-CEP project conducted a survey of 628 clinicians and Medicaid Services (CMS) agree with.”

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As a clinician, I am judged based on whether or not I close a patient’s wound.”

A need to work cooperatively across disciplines for higher quality wound care Thomas Serena Comment & Analysis With the rising importance of high-quality research in the field of wound care and healing, there is a need for key players across the wound care spectrum to collaborate. Writing for iWounds News, one of the editors-in-chief Thomas E Serena (Cambridge, Massachusetts, USA) discusses the ongoing work of the SerenaGroup Research Foundation (SGRF) and how cooperation can be leveraged in wound healing to improve clinical trials, provide education, and allow for the utilisation of new technologies.

INVESTIGATORS HAVE partnered to create cooperative groups in most fields of medicine, and the first wound healing cooperative group formed under the aegis of the SGRF, a not-forprofit corporation based in Cambridge, Massachusetts, USA. This group has brought together nearly 100 clinical

investigators at 60 sites across the globe to address inconsistencies and a lack of standardisation in wound healing clinical trials.

Today, the SGRF Cooperative conducts numerous multicentre clinical trials solely within its network.

Teamwork, progressive trial design,

and technological advances in both data collection and analysis have revolutionised clinical trials in the areas of diabetic foot, venous leg and pressure ulcers, as well as in diagnostics and biomarkers.

The brainchild of a circle of thought leaders that first met in Cambridge in 2003, the cooperative group concept struggled for more than a decade.

A breakthrough, though, arrived when I gathered a small collection of experienced researchers and began conducting clinical trials.

This group formed the nidus of the SGRF Cooperative. As clinicians, regulatory agencies and payers began to demand high quality trials, the SGRF Cooperative blossomed and, today, a central regulatory office manages submissions by the ethics committee for the sites. The burgeoning foundation drafts protocols, selects sites for trials, negotiates budgets and provides education for study coordinators and investigators.

In 2019 the SGRF Cooperative participated in clinical trials in allpatient care settings, from the outpatient clinic to skilled nursing facilities. The research included cellular or Tissuebased Products for Wound Care (CTP), topical oxygen in diabetic foot ulcers, pharmaceutical investigations in venous leg ulcers, genetically modified tissues, biomarkers, wound imaging, biofilms, phototherapy and bacterial load in the ulcer bed. In addition, this year saw the SGRF Cooperative move from single-

device trials to studies evaluating a combination of multiple modalities. An equally robust slate of trials is planned for 2020.

The SGRF Cooperative’s experience has led to the development of unique trial designs for both diagnostics and biomarkers, much needed standardisation for diabetic foot ulcer studies, and protocols that meet the reimbursement requirements for the Centers for Medicare Services.

It has to be said, however, that challenges exist. SGRF must meet the educational needs of the growing Cooperative, which is why a research preconference is planned for Wound Week (16–19 April, 2020, Milwaukee, USA). Interested investigators can learn more by contacting myself at serena@ serenagroups.com. In addition, SGRF has scheduled a series of conferences focused on the principles of conducting trials and unique aspects of wound research.

The development of a cooperative group in the field of wound care has shown promise in enrolling patients in studies, supporting investigators and sites, improving trial design and raising the quality of research in wound healing.

Thomas E Serena is the founder and medical director of The SerenaGroup, a family of wound, hyperbaric and research companies, and is a Phi Beta Kappa graduate of The College of William and Mary (Williamsburg, USA) and Penn State Medical School (Hershey, USA).

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February 2020 | Issue 02

Conference coverage

PROMISE I trial affirms potential of LimFlow system for treatment of “no-option” CLTI patients Initial findings of an early feasibility trial have shown that LimFlow represents a safe and reproducible method of treating patients with no-option chronic limb-threatening ischaemia (CLTI). The results, unveiled by Daniel Clair (University of South Carolina, Columbia, USA), highlight the system’s potential for improving wound healing rates.

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resented at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA), Clair asserted the benefits of percutaneous deep vein arterialisation system LimFlow in “a patient population for whom amputation would otherwise be considered inevitable”. PROMISE I, a prospective, single-arm study launched in 2017 and conducted at seven US centres, found that the amputation-free survival rate at six months was 74% in those treated with LimFlow. Clair said: “It is very encouraging to be able to offer hope to patients who cannot be treated with any current technology.”

As the presenter explained, these no-option patients would have once received a “dead-end angioplasty” in an effort to revascularise the peroneal artery and promote healing, but the chances of success in this situation are very low. LimFlow has emerged as an option for said patients, Clair said.

“The device itself requires antegrade arterial access on the ipsilateral side and antegrade venous access from below the point of entry into the artery,” said Clair, describing how the system operates. “An ultrasound guidance catheter directs a needle into the vein, while a wire advances through the venous system of the foot.

Then, an antegrade valvulotome passes over a wire to lyse the valves, before stent grafts are placed to take branches out of the circulatory aspect, allowing for the

direction of blood flow into the foot.”

PROMISE I aimed to establish the clinical safety of LimFlow—before progression to a pivotal study—and address any operator challenges with the system. Furthermore, the trial sought to determine any patient characteristics and therapeutic parameters which might impact the performance of LimFlow.

Key endpoints listed for the study include the primary safety endpoint of Daniel Clair amputation-free survival at 30 days, in addition to secondary endpoints including amputation-free survival at six months, wound healing, and patency. Only patients of Rutherford 5 or Rutherford 6 classification—with no-option CLTI—were included in the study, whereas those with a life expectancy of less than a year, or on dialysis, were excluded. A critical review of the patients by an independent committee was also conducted to ensure that patients enrolled had no other option.

Of the patients who were included, they had an average age of 71 years and 66% were male. Moreover, a significant proportion also suffered from comorbidities such as diabetes (68%), hypertension (88%) and renal insufficiency (34%), “although end-stage renal disease was an exclusion characteristic”, emphasised Clair.

Regarding the primary endpoint of amputation-free survival (74% after six months), Clair commented: “These are all patients who were heading, in my view, to amputation. With the morality rate among this population, the real issue here is keeping these patients alive with their limbs and that is what this device is designed to do.”

The area of the patients’ wounds was also reviewed by a core lab to ensure accurate presentation, and it was found that while the average size of the wounds may increase initially, which “may be related to the fact that either a toe amputation or transmetatarsal amputation was done in order to remove necrotic tissue”, it was noticeable over time that the wounds actually do go on to heal.

Clair continued: “I think it is critical to understand that even in this setting, wounds do not heal within a month; they take a lot of time and attention, which means follow-up is critical for these patients.” At nine months, 62% of wounds had healed, while 100% had either healed or were on a healing trajectory.

Reflecting on some of the key lessons learned, he concluded: “Obviously for patients who are too far gone for arterial reconstruction, this is not a magic wand that we can use for everyone, and multidisciplinary wound care is critical. Minor amputations need to be managed, allowing for some swelling that is more than what you might see in a typical arterial revascularisation.”

“It is very encouraging to be able to offer hope to patients.”

“Connecting surgical and non-surgical care” key to reducing readmissions for wound patients Inpatient wound services are an essential component of care that can improve the likelihood of patients returning as outpatients, thereby reducing readmissions, Christi Cavaliere (Cleveland Clinic, Cleveland, USA) told the annual meeting of the American College of Wound Healing and Tissue Repair (ACWHTR 2019; 11–12 October, Chicago, USA), in a lecture on plastic surgery and wound care.

CAVALIERE WAS OUTLINING her institution’s creation of a surgical wound care service in 2013, a centre that started as a team that included the plastic surgeon herself and a nurse practitioner.

Often, the Cleveland Clinic’s medical director of wound care explained, patients can find themselves jammed in a revolving door between outpatient and inpatient, creating a conundrum as to where they should end up for wound care and treatment. “I think connecting surgical and non-surgical care is really

Christi Cavaliere

important for our patients. From a big picture standpoint, we need a system that takes advantage of the skills of the wound nurse, the surgeon and the non-surgeon wound care provider,” said Cavaliere.

“We are all in this for the patient, and we already know that coordinated care is going to lead to better outcomes.”

She added: “The wound centre has done a great job in creating a model of care for these patients and getting them the comprehensive management that they need. Inpatient care needs to evolve in this direction as well.”

In Cleveland, the new centre also involved the establishment of a wound fellowship. Cavaliere described the coming together of the disparate elements: “We engaged the hospitalists, the wound nurse team, and then we have the people I like to think of as the wound village, which is the orthopaedic surgeons, urologists, vascular surgeons; all of the people that would tend to work together,” she said.

“For the most part, if a designated team is willing to own the overall care of the patient, other consultants are willing

to participate because they know they can do their part, and the team will take care of the rest.” The system sees Cavaliere and her team attend somewhere in the vicinity of 500 unique inpatients per year.

“We have greatly improved direct communication and the wound photos that we integrated in our electronic medical record (EMR) have been helpful because the wound nurses photograph the pressure ulcers weekly,” she continued.

“I think we have done a good job of being more proactive with the operating

at the same time, and that has been a benefit for our patients.”

Surgical options are necessary, Cavaliere said, in order that individuals might see better outcomes.

Discussing how the Cleveland experience may offer lessons and guidance for others, Cavaliere said: “I think that the inpatient wound service is essential. It might not be something that you can really develop in the same way or even should in a smaller community hospital, but I think that as hospital

The wound centre has done a great job in creating a model of care for these patients.” room. There is nothing more frustrating than going to the intensive care unit (ICU), and seeing somebody with an ulcer who was in the operating room (OR) yesterday for something else. That does not make sense. If you are going to the operating room for something else, we can take care of debriding the wound

systems merge, and you have bigger centres where complicated patients are concentrated, I think that this is really something that we need”.

Cavaliere added: “I do think that we can improve the likelihood of these patients coming back as outpatients, and I think that will reduce readmissions.”

Issue 02 | February 2020

Conference coverage

Multilayer dressing demonstrates benefits for VLU treatment by effective transport of wound exudate A pilot evaluation of a new multilayer wound dressing has confirmed its efficacy for transporting exudate containing toxic matrix metalloproteases (MMPs) away from chronic venous leg ulcers (VLUs).

PRESENTED BY OSCAR ALVAREZ (University Hospital; Rutgers New Jersey Medical School, Newark, USA) at the Symposium on Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA), the study was selected as one of four winning oral abstract presentations. He began: “As you know, there is a hypothesis that chronic wounds have a prolonged, exaggerated inflammatory phase, and even in an uninfected wound, this is likely due to an imbalance of metalloproteases and gelatinases that break down the components of the provisional matrix as the wound tries to heal.”

While acute wound fluid is considered quite healthy for cells, chronic wound fluid is toxic, largely because of elevated levels of gelatinases such as MMP-2 and MMP-9 which, in cases of venous ulceration, prevent significant healing from taking place. Discussing the objectives of the evaluation, Alvarez described the aim of this case series as

two-fold; firstly, to study the absorptive profile of Mepilex Border Flex, ensuring that it is suitably designed to spread fluid away from the wound, and secondly, to determine how the use of the dressing impacts upon the balance of proteases in VLUs as they heal.

The method of the study required 10 VLU patients to be treated with the multilayer dressing in addition to compression therapy. As Alvarez explained, all patients included in the investigation had adequate arterial circulation—defined as an ankle-brachial index (ABI) of more than 0.75—and showed no signs of infection. In addition, all VLUs treated as part of the study were less than 25cm² in size, and follow-up visits were conducted weekly in order to measure and evaluate the wounds.

In order to carry out the study, wound fluid was obtained at baseline (day zero, prior to initial treatment) and once every week, for four weeks, from both the wound and the wound dressing.

Fluorescence imaging supports wound healing by facilitating improved debridement Advanced fluorescence imaging has the potential to decrease bioburden and significantly improve the healing rates of chronic wounds, according to the results of a case series investigation conducted in Cleveland, USA.

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eatured in the prize-winning oral abstract session at the Symposium of Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA), presenter Windy Cole (College of Podiatric Medicine, Kent State University, Cleveland, USA) emphasised that an optimally prepared wound bed, which promotes healing, must be regularly debrided to remove devitalised tissues, while a reduction of the bacterial load is also necessary. Despite the elimination of debris and slough at the base of the wound, Cole questioned “Are we really getting rid of bioburden and affecting the bacterial contamination of the wound?”

The emergence of a point-of-care fluorescence

Furthermore, homogenates were analysed using a custom multiplex kit for MMP-9.

Explaining how the dressing is structured, Alvarez outlined: “The dressing has a printed back layer, which is waterproof, a retention layer that actually retains a lot of the fluid, and a spreading layer, which is really the unique part of the dressing, as well as a foam layer which rapidly absorbs exudate and a silicone layer that prevents trauma to the wound upon dressing removal.”

“A lot of people do not realise that when you put an absorptive dressing on a venous ulcer and you subsequently compress the wound,” Alvarez added, “it changes the complete profile of the dressing”. Furthermore, the presenter emphasised that if the size of the wound is over 60% of the surface area of the pad within the dressing, it will not succeed because the dressing will not absorb enough.

Results of the evaluation demonstrated a 46% decrease in wound fluid MMP9 levels over the course of two weeks (p=0.042), following treatment with Mepilex Border Flex. After four weeks, those levels had been reduced even further, decreasing by 79% (p=0.029).

Alvarez also revealed that significant levels of MMP-9 were detected in the spreading layer and retention layer of the dressing, which was supported by analysis that show MMP-9 had been transported distally up to 4cm away from the wound.

Alvarez concluded: “The mean MMP levels decreased nearly 50% in

imaging system that can help clinicians with bacterial-targeted debridement and bioburden management, in the treatment of chronic wounds, is considered to be an innovation with high potential, prompting an observational case series.

According to Cole, 11 chronic wounds in the lower extremities were imaged weekly with the device, highlighting both bacterial fluorescence and wound area over 12 weeks (or until either healing or lost follow-up). Once images Windy Cole positive for bacterial fluorescence developed, they were used to guide debridement to those specific regions.

Following this stage, data from each assessment were categorised into two groups—either a fluorescencepositive assessment or fluorescence-negative assessment—while the percentage of weekly change in slopes of wound area were also calculated from linear regressions for each category.

Ultimately, six out of the 11 wounds healed during the 12-week case series. Cole outlined that at week one, the average area of the wounds was 8.1cm², with 10 of the wounds exhibiting red fluorescence to indicate the presence of bacteria. Moreover, this bacterial fluorescence continued for 3.7 weeks on average, while no wounds began to heal during the period in which red fluorescence remained present.

With the support of information provided by fluorescence images, it was then possible to better debride the affected area to an appropriate level. It was also revealed that in 9% of cases additional debridement resulted in a high billing code. Overall, the average weekly change in wound area increased (6.5±10.8) during periods in which bacterial fluorescence was present, compared to a significant decrease (-27.7±10.1, p=0.048) after the targeted debridement and further

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Oscar Alvarez

The mean MMP levels decreased nearly 50% in two weeks, and this was statistically significant.” two weeks, and this was statistically significant. Mepilex Border Flex also draws the chronic wound exudate outwards, and for use with VLU compression, optimal absorption depends on the capacity of the dressing and therefore size selection.”

treatment had successfully eliminated the bacteria.

Results of the study, according to Cole, suggest that the aid of fluorescence information improved efforts to reduce the bacterial load and helped to foster a better environment for the wound to heal. Cole posited that the findings of this case series advocate the incorporation of fluorescence guidance into standard of care as a way of boosting wound healing trajectories, improving patient outcomes and guiding clinicians to more appropriate treatments.

She added that the increased revenues this technology can offer to outpatient wound centres represent a significant benefit.

Cole concluded: “I feel that incorporation of fluorescence guidance into standard of care could help to increase wound healing trajectories, improve outcomes and lead to more appropriate wound care therapy, because it can tell us whether the dressings we are

[The] incorporation of fluorescence guidance into standard of care could help to increase wound healing trajectories.” applying to our patients are actually working. There are a lot of dressings and wound ointments that tell us they will reduce biofilms and bioburden. We cannot see this with our naked eye, but we can with the fluorescence imaging camera.”

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February 2020 | Issue 02

Lower-limb amputations

Following the ilegx philosophy to prevent lower-limb amputations Michael Edmonds Comment & Analysis In the UK, the lower limb amputation rate has not improved significantly since 2012. One of the main reasons for this is the incidence of infection and ischaemia in patients with diabetic wounds. In this article, Michael Edmonds (King’s College Hospital, London, UK) turns his attention to the importance of preventative practices and interdisciplinary approaches, and explains how a simple tool can help to improve the standard of care for all patients suffering from limb-threatening chronic wounds.

T

he term ilegx represents an interdisciplinary leg initiative that was founded at the Charing Cross (CX) Symposium (London, UK) in 2008. A key goal of ilegx is to encourage interdisciplinary collaboration that spans primary and secondary services, as well as the development and implementation of best practice approaches to save legs.

Now in its 12th year, ilegx will again be part of iWounds at the CX Symposium (21–24 April 2020, London, UK).

This ilegx philosophy aims to accomplish the early diagnosis of the causes of leg and foot tissue loss and to promote interdisciplinary collaboration in the management of these conditions.

The development of this philosophy led to the creation of an ilegx algorithm, which encompasses both the diagnosis and definitive management of leg and foot tissue loss, dividing the aetiologies into vascular and non-vascular causes.

The category of vascular ulcers (70%) comprises ischaemic arterial, renal arterial, diabetic arterial, inflammatory, venous and lymphatic ulcers, caused by derangement of macro- as well as microvascular pathophysiology; non-vascular ulcers (30%) are caused by non-arterial diabetic pathological changes, pressure and a variety of other causes.

Illustrated in the shape of a turning wheel, the ilegx algorithm highlights diagnostic approaches to wound care and reminds specialists of key management steps, identifying which disciplines should be included in the circumstances of a particular diagnosis. It is, above all else, a useful tool which simplifies this highly complex disease area. The “ilegx wheel”, as shown in Figure 1 (right), was developed with the goal of clarifying the interdisciplinary nature of the causes leading to leg and foot tissue loss, and is designed to speed up patient referral in order to prevent this.

Once the correct diagnosis is made, the “ilegx wheel” is set to the respective causation/slice. Consequently, the “ilegx wheel” provides a specific

indication of how to manage a specific case of leg or foot tissue loss using the patient’s diagnosis. It also determines the players who will be involved in the interdisciplinary team at hand. Figure 2 (right) shows the management steps and interdisciplinary team needed to treat the ischaemic arterial ulcer.

With there being more than 40 reported causes of leg and foot tissue loss, patients can suffer from this condition with either a single aetiology, or with multiple causes. It is hoped that the ilegx approach will unravel the aetiologies of leg and foot tissue loss, in order to diagnose and treat patients more effectively.

As an example of the ilegx approach, the management of the diabetic foot ulcer can be summarised according to the wheel.

A diabetic foot ulcer is a sign of systemic disease and successful management requires the expertise of an interdisciplinary team who can provide integrated, focused care in a diabetic foot clinic. The team has to be aware of three distinct pathologies in the diabetic foot— neuropathy, ischaemia and infection—but on a practical level, the diabetic foot can be divided into two entities: the neuropathic foot with its characteristic plantar neuropathic ulcers, and the neuroischaemic foot with its ulcers on the margins of the foot.

Members of the team will include a podiatrist, nurse, orthotist, radiologist, microbiologist, vascular scientist, surgeon and physician. It is helpful if the team works closely together, within the focus of the diabetic foot clinic, and meets regularly for joint ward rounds and X-ray conferences. Each team member should be available in an emergency, though some roles may overlap depending on local expertise and interest.

Furthermore, all members of the team must realise that neuropathy often delays the patient’s presentation, because they will not have pain and may not take the lesion seriously. This is a mistake that can also be made by medical

attendants, who have been educated in a diagnostic process that assumes pain is a reliable indicator of the seriousness of the presentation. This is not true in the diabetic foot.

Day-to-day interdisciplinary treatment is carried out by podiatrist, nurse, orthotist and physician in the diabetic foot clinic. Further interdisciplinary management can be achieved by holding regular joint clinics when appropriate groups of patients are assembled in the diabetic foot clinic. These are held regularly with vascular, orthopaedic and plastic surgeons, and through these specialist clinics, it is possible to organise a ‘fast-track’ service with a ‘one-stop’ visit. In the joint clinic with the vascular surgeon, the need for angiography and angioplasty can be rapidly agreed upon and promptly carried out as a day case where appropriate. The results can be quickly reviewed and further action taken thereafter.

The diabetic foot clinic should provide rapid access, early diagnosis and a prompt solution for patients with foot problems. Emergency services can be run concurrently with routine clinics so that patients with new ulcers, pain or discolouration can be seen the same day.

Rapid admission to hospital for the foot in jeopardy can also be arranged through

long-term care and follow-up.

Care of the neuroischaemic patient also involves routine preventative foot care, the updating of education in order to avoid trauma, diagnosing problems early, rapid and aggressive care of ulcers, regular arterial and graft surveillance, and the provision of statins and aspirin for secondary prevention of arterial disease. Thus, the long-term followup care of the diabetic patient with peripheral vascular disease is an essential component of successful management, and staff, patients and administrators need to be aware of this. The ideal forum for management of the acute episodes of infection and ischaemia is a combined vascular/diabetic foot clinic.

Aggressive treatment of infection is important both in the neuropathic foot and the neuroischaemic foot, starting with wide-spectrum antibiotic therapy and then targeted therapy according to the bacteria isolated. It is important to have a working knowledge of the principal bacteria and their local antibiotic sensitivities, including awareness of the prevalence of resistant organisms.

However, in every patient, individual sensitivities of each organism isolated on culture should be sought to guide rational antibiotic therapy. There should also be close cooperation between the

Figure 1: Ilegx wheel

Figure 2: Ischaemic arterial

The diabetic foot clinic should provide rapid access, early diagnosis and a prompt solution for patients with foot problems.” this emergency service.

It is important to realise that a combination of neuropathy and ischaemia can be devastating. There is a disconcerting speed of the natural history and a wide range of comorbidities are found in patients presenting with both conditions, making these neuroischaemic patients extremely vulnerable. Furthermore, by the time that the peripheral arteries are involved, the ischaemic patient is likely to have neurological and vascular impairment elsewhere. It is also important to be aware that neuroischaemic feet need

microbiology laboratory and the diabetic foot service, while antibiotic therapy should be accompanied by debridement of infective and necrotic tissue.

The majority of major amputations are preventable, and early referral and interdisciplinary working are the key to saving legs, as well as fulfilling the ilegx vision of significantly reducing the number of lower limb amputations.

Michael Edmonds is a professor of diabetic foot medicine at King’s College, London, UK, and consultant physician, King’s College Hospital, London, UK.

Issue 02 | February 2020

Addressing the silent crisis of venous leg ulcers and its impact on patients With the level of spending on wound care in the billions of pounds, both the financial and health-related impact of venous leg ulcers cannot be understated. Dan Carradice (Hull York Medical School, Hull, UK) speaks to iWounds News about the latest report by the All-Party Parliamentary Group on Vascular and Venous Disease, which articulates the extent of this important issue, and what can be done to improve care in the UK.

How did the report, “Venous Leg Ulcers: A Silent Crisis”, come about, and why are venous ulcers an important issue?

The thing to say first is that vascular disease is an unwitting victim of the widespread misunderstanding and misdirection of healthcare attention, and I think that this is true all the way from strategy and planning, down to individual patient care. It is clear that vascular disease is the most common cause of death in UK adults, the most common cause of limb loss, and results in a significant level of physical, mental and psychological morbidity across the country. Despite this, it has received precious little attention compared to other diseases, such as cancer, and when it is considered it is usually fragmented, with all attention limited to heart disease and stroke.

The predominant interest of those involved in the management of vascular disease is targeted towards arterial disease, and it is against this backdrop Dan Carradice that venous disease sits in near silence.

I think that this report came about because both patients and their carers are clamouring to be heard, while healthcare professionals are battling to improve care quality and outcomes. For this reason, we have been working with organisations such as Legs Matter, Lindsay Leg Club, and now members of parliament in the group to produce this report, raising awareness of such an important condition.

In terms of the second part of the question, I think that this is an important issue because lower limb venous reflux is one of the most common causes of disease in adults, with a prevalence of about 40–50% in adults overall. It is difficult to know how many people have active venous leg ulcers, as they are frequently misdiagnosed, but at least 200,000 people seek help for these ulcers annually. There are another 420,000 leg wounds treated every year which never receive a formal diagnosis, and we also have some detailed epidemiological studies which estimate a prevalence of around 0.7%, which would equate to around 400,000 active ulcers in the UK.

What are some of the key reasons for the development of venous leg ulcers, and how do these wounds impact patients’ lives?

Venous leg ulcers are caused by high pressure in the veins (venous hypertension), which initiates an inflammatory condition within the skin and the soft tissues of the leg. This results in the breakdown of the skin. There are a range of causes for this increase in venous pressure, but the most important and common, by far, is reflux in the superficial veins of the legs. This, in turn, is also caused by an inflammatory condition in the vein walls, which results in a loss of valvular function.

Ulcers have a profound impact on patients’ lives; they can be painful, distressing and have been shown to significantly limit health-related quality of life, due to physical limitation, social isolation and psychological strain. One study I was involved with performed a

detailed evaluation of objective health-related quality of life, which found that venous ulcers have a similar impact on patients as that of end-stage heart failure.

Is there enough awareness of the physical, social and psychological problems patients with venous leg ulcers experience?

Sadly, I think we are far from where we need to be.

We know this from our own experience as clinicians, but the parliamentary group has also received testimony from multiple people who have been through this condition and suffered from a lack of awareness.

Patients themselves do not understand the significance of their first ulcer when it does occur, as the underlying venous health issues and their implications are not well known. Usually, they will go to see their GP and, if the GP does not know what the wound is, then the patient will try some antibiotics and perhaps try to dress it with a simple adhesive dressing or dermatological creams. In some cases, these patients spend years having such a dressing placed on the wound by a GP practice nurse and never receive access to a vascular specialist. In fact, 75% of patients with known ulcers never receive an appropriate assessment.

For those who are lucky to be diagnosed with a venous leg ulcer, it is still rare that they make the transition from primary to secondary care. Primary care usually involves the conservative management of wounds with dressings, and the quality of these dressings is often quite poor. When they are referred to hospital, some of the commissioning policies can make it challenging to treat them expeditiously, while the lack of investment in this area means that services fail to develop to the level required.

Venous ulcers have a similar impact on patients [in terms of quality of life] as that of end-stage heart failure.”

As part of the report, you wrote about geographical variation in the provision of venous treatments. Could you explain how this “postcode lottery” affects patients?

Geographical variation results in significant inequality of access to NHS services and a failure to deliver clinicallyand cost-effective treatment recommended by the UK’s National Institute for Health and Care Excellence (NICE). This not only leads to poor healthcare, but also inefficient and inequitable use of NHS funding. Both the Government and NHS England are committed to reducing the level of inequality, and, as such, we need to focus on areas like this where inequality is prevalent.

Venous ulcers

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We performed a study where we assessed the published policies of clinical commissioning groups (CCGs) across England, with regard to whether they allowed or prevented the application of NICE’s evidence-based guidelines for the treatment of this venous reflux. Only a third of CCGs had a policy which did not actively prevent the application of these guidelines and evidence-based treatment, while the others employed a range of restrictive or rationing mechanisms, leading to a wide variation in access to treatment. In total, over 90% of patients presenting with superficial reflux do not receive the recommended, evidence-based treatment.

Geographical variation results in significant inequality of access to NHS services.”

What are the key findings of the report with regard to the current state of venous leg ulcer care in the UK?

I think we have found that there is a widespread lack of effective information and knowledge at multiple levels; the patients themselves, among communitybased healthcare professionals and, to a degree, at the level of secondary care. What we have also found is that there is a lack of awareness among commissioners, which has led to a drop in investment for treatment of these conditions and, in turn, a lack of infrastructure in secondary care to be able to deal with them. The All-Party Parliamentary Group actually did a piece of research focusing on the proportion of trusts who had a specific team for delivering this care, and they discovered that only half of the trusts they contacted had a team in place. In addition, significant elements of variation in access and the quality of treatment were found.

Looking ahead, what recommendations do you and your peers offer in the report to improve the quality of venous treatment for patients?

To sum up the most important points from the report, I think that education is a hugely important aspect and this needs to be integral, at both a policy-making level and the community level, as well as at a commissioner and secondary-care level. Moreover, there needs to be a separate arm for patients because they need to know that the longer it takes for these wounds to heal, the harder the task becomes. We have to make sure these patients realise that, by delaying care, they are reducing the ability of healthcare professionals to address this problem, so education is crucial.

The second key element relates to healthcare services; we need to have streamlined and agreed pathways for getting patients from the community into expert assessment, secondary care and, ultimately, expedited treatment. The only way we can do this is by ensuring that we have effective organisation and commissioning in this area of wound care, along with a strong emphasis on education.

We have a solid evidence base upon which we can dramatically improve the outcomes for these patients and enable health services to make considerable financial savings, even in the short-term. We simply need to overcome these practical hurdles and apply our knowledge and skills to transform care in this common and debilitating disease.

Dan Carradice is an academic vascular and endovascular surgeon at Hull York Medical School and Hull University Teaching Hospitals NHS Trust (Hull, UK). He is the clinical lead for vascular surgical services and is actively involved in leading research aiming to improve quality of life, and save life and limb.

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February 2020 | Issue 02

Interview

Profile

Una Adderley

As director of the National Wound Care Strategy, a programme that aims to improve the quality of wound care across the UK, Una Adderley is one of several figures in the nursing community leading the drive for change. Speaking to iWounds News, Adderley explains how she entered the field of tissue viability, the ways in which it has changed throughout her career, and why it must evolve over the next few years, emphasising that “there are still so many people not receiving care in line with the research evidence”.

Why did you decide to pursue a career in nursing and how did you arrive at the specialty of tissue viability?

I think, to begin with, that it was an act of rebellion.

I was supposed to go to university, but I decided against it at the time, which is ironic given how I have spent much of my working life. Instead, I chose to become a nurse, as I wanted to do something practical.

Eventually, leaving nursing for a few years, I realised that community nursing was probably better suited to my talents, and I became interested in tissue viability.

During my first week in the community, I visited a patient who had terrible leg ulcers. I had never seen anything like it, so I decided that I had to find out more about what this condition was, and how to provide care.

Who were some of your key mentors when you first entered the tissue viability field and how did they guide your journey?

Initially, I managed to go on one of the early leg ulcer courses run by Christine Moffatt but soon after I started working as a lecturer practitioner at the University of York, and met Nicky Cullum and Andrea Nelson, who were researching leg ulceration. I ended up working alongside them on the VENUS trials for 10–15 years. I learned a huge amount during this period about research and clinical practice, and this experience has been hugely instrumental in how I view wound care.

During your time as a tissue viability nurse, how have practices developed and transformed?

Unfortunately, not as much as I would have hoped, given that the evidence has been there for a long time. People are still not putting it into practice. It is interesting though that conference programmes are becoming more evidence-based, which I fully welcome. I know that there are many gaps in the research evidence, but when it exists, we should be using it as the starting point to inform care. I find it staggering that there are still so many people not receiving care in line with the research evidence.

To what extent can technology play a role in advancing the practice of wound care, for both physicians and nurses?

I think this is going to be of key importance. You can look at technology in terms of gadgets for treating wounds, but I do not think that this is where the real benefit is going to come; what will be truly interesting is the development of digital applications for capturing information about the patient and measuring wounds electronically. I think that this technology can also provide more access to information for patients and carers, so this could be a really exciting area to keep any eye on.

As a lecturer in community nursing, how important is the role of education in improving practice?

Education is, of course, very important and I think

technology will be very interesting here, as we can offer nurses the opportunity of high-quality, online education. The reality though is that the work we do is difficult and practical, so you cannot teach everything online. I am concerned that people do not have access to the education they need. Technology can play a role in increasing access to education, but I think there is a danger in assuming that education is the only answer.

It is certainly part of the solution, but there are already clinicians out there who know what they should be doing, but cannot because services are not organised in a way that allows them to deliver appropriate care.

What role can societies, such as Legs Matter and the Tissue Viability Society, play in raising awareness of wounds and their impact?

The biggest issue today would certainly be low leg ulceration, which accounts for the largest group of patients suffering from wounds.”

I see these bodies as being absolutely essential in raising awareness about the impact of hard-to-heal wounds such as leg ulcers and pressure ulcers. I was involved in the development of Legs Matter, which came about because we recognised that we needed to spread the word about what good care looked like. It is only when you realise the extent of how awful it is to be living with some of these conditions that things might change. Our hope is that if we can help patients and carers to have a voice, this will hopefully influence decision-makers at the top.

In terms of the key issues and complaints faced by the nursing community, which wounds are currently presenting the most challenges?

The biggest issue today would certainly be lower leg ulceration, which accounts for the largest group of patients suffering from wounds. However, I would have to guess that the highest number of complaints relate to patients with pressure ulcers, especially as the public is now more aware that pressure ulcers should not be happening. In the past, it was accepted that this is what occurs when you become old and frail, but today, people are beginning to understand that these wounds are nearly always preventable.

Can you explain some of the key aims and initiatives of the National Wound Care Strategy and how this will benefit patients?

There are three key clinical areas: lower limb wounds, pressure ulcers and surgical wounds. In terms of the latest developments, we have some recommendations for the lower limb that have been sent out for consultation, and we are planning to start working with pathfinder sites in early 2020. We need to test what is the best way of implementing the recommended changes; we all know that just publishing new guidance does not lead to improvement. We need to examine how best to change practice. There also needs to be a focus on data and information, including ideas about smart ways of capturing information in a consistent, standardised way. We have plans to make some online, free-toaccess educational modules available, so that wherever you work, you can access good quality education.

Finally, there is work that needs to be done around the classification of wound care products, and we are trying to come up with a system that will be clear and acceptable for everybody.

During your career as a nurse, what have been some of the most memorable or challenging cases you have encountered?

When you work as a tissue viability nurse you see some shocking sights but sometimes the most memorable cases are those where small successes are achieved: finding a form of compression that is acceptable to

Issue 02 | February 2020

Interview

13

Fact File

Qualifications

1989 BA, University of York, York, UK 1996 BSc, Leeds Metropolitan University, Leeds, UK 2005 MSc, University of York 2012 PGCE, Teesside University,

Middlesbrough, UK 2013 PhD, University of York

Academic appointments (selected)

1999–2002 Research nurse, University of York 2010–2012 Senior lecturer on research methods, School of Health and Social Care, Teesside University 2012 Fellow, The Higher Education Academy, Heslington, UK 2012–2018 Lecturer in community nursing, School of Healthcare, University of Leeds

Professional appointments (selected)

2003–2008 Tissue viability specialist nurse, North Yorkshire and York Primary Care Trust, York, UK 2008–2010 Team leader, specialist nurses, North Yorkshire & York Community and Mental Health Services, York, UK

Offices (selected)

someone who would not previously use compression but now no longer has recurrent leg ulcers, or sorting out a case of wound malodour so a grandmother is no longer too embarrassed to spend time with her grandchildren; such successes are immensely rewarding.

Is there a moment in your career that you are particularly proud of, either as a nurse or an educator?

At my graduation ceremony when I was lining up waiting to receive my doctorate, we started talking about the different colours of our gowns. The newly-qualified nurses in front of me were blown away that a clinical

nurse was being awarded a PhD. It felt good that I was hopefully inspiring the next generation.

What are some of your hobbies and interests away from wound care?

I can usually be found with my nose in a book, or some other kind of reading material, or taking some form of exercise in an attempt to slow down the ravages of middle age. I also enjoy walking, playing the piano (badly) and the usual stuff like time with my family and friends. In some ways, I go from one extreme to the other: incredibly busy at work, and possibly a bit lazy outside of it.

2002–2006 NICE (National Institute for Health and Care Excellence) Guideline Development Group, surgical site infection (SSI) 2007–2009 Chair, North East Tissue Viability Nurses 2016–2018 Founder member, Legs Matter 2017–Present Panel member, National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Primary Care Panel 2018–Present Director, National Wound Care Strategy programme

14

February 2020 | Issue 02

Foot wounds

Multidisciplinary team approach needed for limb salvage and treatment of wounds “When it comes to complicated wounds, it is important to acknowledge that we cannot do it alone,” argued David Davidson (Buffalo Medical Group, Buffalo, USA), before emphasising that “we need a truly multidisciplinary limb preservation team” during a presentation at the Desert Foot Conference (4–7 December 2019, Phoenix, USA).

I

t is estimated that approximately seven to eight million people in the USA are affected by nonhealing wounds, while nine million are thought to be suffering from peripheral arterial disease (PAD). “In terms of diabetes,” Davidson added, “there are about 30 million struggling with this disease in the USA. This is a very expensive disease to manage, and it is incredible how much is spent on it worldwide.”

In addition to the podiatrist and vascular specialist, the speaker underlined that both the patient and their caregiver must be part of the wound care team. He said: “We need to get both of these persons involved in the care, as this could eliminate some of the lack of judgement these patients encounter as well as issues with non-compliance.”

In a wound care setting, which may be a specialist

centre or virtual, the interdisciplinary team works to coordinate inpatient and outpatient services, with the goal of treating the patient and preventing recurrence.

According to Davidson, the literature shows that a delay in seeking treatment does slow or prevent healing and has a direct impact on morbidity and mortality. “As part of the process, we exclude and/or treat infection, speak to immune specialists who can take ownership of the patient’s antibiotic coverage, and rule out any vascular disease or—where found or suspected—refer said patient to a vascular surgeon or specialist,” the presenter explained.

Davidson also highlighted the role of the vascular surgeon in this interdisciplinary team, who must decide whether to perform a bypass endarterectomy or another procedure, such as atherectomy or balloon angioplasty, on patients with critical limb ischaemia (CLI). Citing the results of the SPINACH study—a

In the teams that work with one another best, the key is communication.” multicentre investigation that enrolled 548 patients— the speaker pointed out that no significant difference was found between the group who underwent surgical reconstruction and the cohort who received endovascular therapy, in terms of three-year amputation-free survival.

However, based on his conversation with a vascular surgeon, Davidson was keen to acknowledge that there are a number of different views in this debate. “Speaking to a vascular surgeon, who probably completes around 40–50 angiograms a week, I asked why, despite conducting so many angiograms, she only carried out

Injectable adipose matrix improves healing rates for foot wounds in high-pressure areas The use of a new tissue allograft, which can be injected into areas of high pressure in the foot, has demonstrated clinical improvement in a number of real-life cases, according to a presentation at the Desert Foot Conference (4–7 December 2019, Phoenix, USA).

Described as an “adipose matrix”, Jodi Schoenhaus (Foot, Ankle and Leg Vein Center, Boca Raton, USA) told those in attendance that “this technology is going to change the wound care world”.

DEVELOPED BY NON-PROFIT organisation MTF Biologics, the Leneva dermal matrix was developed to “advance the treatment of complex surgical wounds, […] aid in tissue reconstruction” and support wound closure “by providing protective coverage and promoting tissue integration”, according to a press release.

Introducing the matrix, Schoenhaus said: “This product is the first of its kind in this arena, and we are able to use the graft for diabetic foot ulcer prevention, fat pad reconstruction, pressure ulcers, and even deep tunnelling wounds.” It was explained further that Leneva is produced by taking tissue from a donor, before it is processed by MTF Biologics and ultimately injected in (or placed around) a patient’s fat pad.

The presenter revealed that there are many possible recommendations for use

in patients who have significant fat pad atrophy, high-pressure wounds or highpressure areas in the foot. Discussing the procedure, Schoenhaus outlined that “what we have at day zero is a matrix, so you are injecting the framework of the tissue which, over the course of seven days, leads to the development of cytoskeletal cells and the infiltration of some of the adipose scaffold”.

After another seven days, it has been found that adipose sites and cell differentiation can be seen, generating new tissue.

Jodi Schoenhaus

three bypass procedures last year.”

He continued: “With open bypass, in her hands, limb salvage rates were as high as 80% over five years, with a mortality rate of less than 6%, and the complications were limited. I wondered why she was not completing more bypass procedures; she said that the complication rate she encounters in performing bypasses is still about three times higher than that of endovascular therapy.”

Turning his attention back to the potential of a multidisciplinary approach, the presenter revealed that by implementing this system, The Netherlands was able to decrease amputation rates by 34% in less than two years, with similar results achieved in Finland, Italy, Lithuania and the UK by wound care units involving vascular specialists. “In the teams that work with one another best, the key is communication. If you are in the same centre, it is generally easier to communicate, but if not then you must stay in contact so that patients can be seen and referred as quickly as possible,” Davidson asserted.

The speaker also acknowledged the need for guideline-specific regulations; these do not have to be exactly the same as what has been published, he emphasised, but need to be close so that everyone in the wound care arena is “on the same page”. “In addition, we have to decide which guidelines are more appropriate for the studies we are conducting and most importantly, the population we are dealing with,” Davidson added.

He concluded: “When the perfect balance has been achieved between medical management and maximum perfusion, as well as offloading, moisture balance, infection control and patient cooperation, the wound is much more likely to heal in a rapid fashion. Balancing all of these various elements is the job of the wound healing specialist, who must work to organise the internal surgeon, nutritionist, vascular specialist, nurse, podiatrist and several other roles: in situations like this, they must choose wisely.”

“It really is a new solution for foot cushioning,” commented the speaker, who added that “you can use it instead of external loading and offloading pads to increase patient compliance and ensure adherence to your recommendations.”

Other benefits were also highlighted, with Schoenhaus articulating that Leneva can be used to reduce peak pressure and offload high-pressure areas.

“Above all, we want to decrease pain and inflammation, support healing of non-infected wounds, allow for an improved cosmesis, and improve quality of life,” Schoenhaus said, before pointing to other patient populations who could benefit from Leneva; these include “rheumatoid arthritic patients where the disease is causing joint deformities and skin breakdown” and “traumatic atrophy where there is no fat pad and many other situations causing pain and discomfort”.

Schoenhaus then provided a closer analysis of success with a dermal filler in treating a series of patients, which sparked the concept of internal offloading. Regarding the first, she said: “The patient came to me in December 2016: he was neuropathic, had a callus foot-type, significant atrophy, as well as a non-healing area that had been present for years. The recommendation was multifarious and involved sesamoids, local skin grafts, offloading and debridement, but nothing was working.” The wound closed within one week and, to date, has not recurred,

Schoenhaus revealed.

Another case involved a patient with grade one ulceration who had peripheral arterial disease and was not a candidate for revascularisation. “Through the use of a dermal graft, we were able to inject an area, offload post-procedure with a pad just for a couple of weeks, and ultimately heal her ulcer,” said Schoenhaus.

Concluding, she stated: “The outcome of these cases, and our findings, is that with these injections there is a clinical improvement, a decrease in peak pressure at the site of injection (as well as in the dermal layers), and a decrease of keratin build-up in the callus tissue. I think you should start to implement this technique and consider which patients you can apply it to in your own practice, as it is going to be a game-changer.”

Above all, we want to decrease pain and inflammation, support healing of non-infected wounds, allow for an improved cosmesis, and improve quality of life.”

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February 2020 | Issue 02

Diabetic foot

Exploring concepts in surgical offloading from the current IWGDF guidelines Raju Ahluwalia Chris Manu Ines L Reichert Comment & Analysis First revealed at the International Symposium on the Diabetic Foot (22–25 June 2019, The Hague, The Netherlands), new guidelines from the International Working Group on the Diabetic Foot (IWGDF) have updated recommendations for the practice of diabetic foot care and treatment. This article underlines the latest approaches to offloading and considers the future of this treatment option for patients with diabetic foot wounds.

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eripheral neuropathy leads to changes in gait, foot deformity and soft tissue, all of which can further elevate mechanical stress.1–3 Thus, the combination of loss of protective sensation, and elevated mechanical stress, leads to tissue damage and the development of a diabetic foot ulcer (DFU).4 Once a DFU forms, healing is chronically delayed if the area is not effectively offloaded.4,5 Local wound management, infection management, revascularisation, and pressure offloading are all required, but offloading is arguably the most important of these interventions.6 Sadly, unhealed diabetic foot ulcers are a prelude to 84% of lower extremity amputations,1 so it is important to heal ulcers quickly and keep them healed.7 The IWGDF presents their own review of the literature with expert panel members to suggest new best practice guidelines, which are devised using a series of clinical questions and critically important outcomes to conduct a systematic review of the medicalscientific literature.

Recent guidelines on offloading focus on the management of neuropathic foot ulcers, with the prevention of foot ulcers now covered in the updated 2019 IWGDF prevention guideline.8 The new guidelines follow a friendlier format where possible, so they can outline the following, as shown in Figure 1 (right): The first-, second-, third- and fourthchoice of offloading treatment to heal a neuropathic plantar forefoot or midfoot ulcer.

Added one new recommendation on considerations for choosing between either a total contact cast or nonremovable knee-high walker.

Added three new recommendations on offloading treatments for people with

neuropathic plantar forefoot ulcers that are complicated by infection or ischaemia.

Added a new recommendation on offloading treatments for people with neuropathic plantar heel ulcers.

In total, nine recommendations were produced in 2019, but only four were graded strong by the strength of recommendation, and high to moderate depending on the quality of evidence: a) A non-removable knee-high offloading device is the first-choice of offloading treatment. Strong; High. b) The use of a removable kneehigh and removable ankle-high offloading device is to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to non-removable offloading exist.

Strong; Moderate. c) In a person with diabetes and a neuropathic plantar forefoot or midfoot ulcer, do not use, and instruct the patient not to use, conventional or standard therapeutic footwear as offloading treatment to promote healing of the ulcer, unless none of the above-mentioned offloading devices are available. Strong; Moderate. d) In a person with diabetes and a nonplantar foot ulcer, use a removable ankle-high offloading device, footwear modifications, toe spacers, or orthoses, depending on the type and location of the foot ulcer, to promote healing of the ulcer. Strong; Low. Since the last guidelines, total contact casting (TCC) is no longer the only treatment to effectively heal plantar forefoot ulcers. Prefabricated removable knee-high walkers that are rendered nonremovable are thought to be beneficial due to more evidence being established in the last four years.

Even so, it has been emphasised that there is a need to measure factors impacting on mechanical stress levels that lead to different healing outcomes, which include: Plantar pressure, Shear stress, Weight-bearing activity that includes steps and standing duration, Adherence to using offloading devices.

A lack of standardisation leads to technical difficulties in comparing modalities, and there are still little data available on the value of offloading in healing plantar foot ulcers complicated by infection or ischaemia, rearfoot ulcers, or non-plantar ulcers.

Thereafter, recommendations become less defined, with lower levels of evidence and quality for their use.

Medical treatments are only described with weak evidence. However, if nonsurgical offloading fails, the guidelines only consider surgical offloading interventions for healing metatarsal head and digital ulcers.

Surgical interventions

Surgical offloading has primarily been applied to heal foot ulcers in selected patients, typically where other nonsurgical offloading interventions have failed. The current IWGDF tends to include studies that have case control or higher-level evidence, which can mitigate the majority of surgical studies.

The treatments identified in the current IWGDF include tendon procedures such as toe flexor tenotomy and achilles tendon release, predominantly for pressure release. However, we are now seeing other surgical techniques and

soft tissue procedures that could be conducted in the clinic, adjuvant modalities followed by bony off-loading in the form of exostectomy, and foot reconstruction that require a formal surgical process.

Tenotomy

This is a promising intervention in patients with hammertoes and recalcitrant digital ulcers who, in particular, fail with non-surgical treatment. The procedure works for a flexible hammertoe by decompressing the tight flexor tendon to allow the toe pulp to take weight again, and is performed in an outpatient setting, without the need for subsequent immobilisation.

However, the quality of the evidence for this recommendation was low; nevertheless, benefits of digital flexor tenotomy may outweigh the potential harm. The cost-effectiveness of this procedure has not been evaluated.

Therefore, the strength of this recommendation was weak.

Achilles tendon release and metatarsal offloading

The question asked here was “will persons with diabetes, and a neuropathic plantar metatarsal head ulcer, consider using Achilles tendon lengthening, metatarsal head resection(s), or joint arthroplasty to promote healing of the ulcer, if non-surgical offloading treatment fails?”.

Again, surgical offloading techniques are only considered for those hard-toheal plantar ulcers with non-surgical offloading interventions.9 These techniques change the foot structure and therefore provide a more permanent

Figure 1: Flow diagram on the recommended offloading treatment for a person with diabetes and a foot ulcer

modalities used in offloading that were not described in the latest guidelines, supported by a number of systematic reviews/meta-analyses for surgical management of the diabetic foot.

In order of invasiveness, we describe

offloading solution for areas of elevated mechanical stress, even when the patient is not adherent to wearing an offloading device.

Surgical offloading potentially comes with an increased risk of complications

Sadly, unhealed diabetic foot ulcers are a prelude to 84% of lower extremity amputations, so it is important to heal ulcers quickly [...].”

Issue 02 | February 2020 compared with non-removable offloading devices alone, but have a higher efficacy of healing, shorter time-tohealing [by 24–43 days, p<0.05]. Also, early data from a recent low-quality controlled study of metatarsal head resection(s) found significant decreases in hospitalisations and infections compared to non-surgical offloading controls (p<0.05).10

Adjuvant local antibiotic loading

It is presumed that treating infection, coupled with surgical offloading and biofilm disruption, allows a non-healing ulcer to heal combined with offloading.

Local antibiotic delivery can yield very high concentrations of antibiotics exclusively in targeted areas, which cannot be achieved by systemic therapy, despite it being useful in poorly perfused tissues.

This has been described with the current focus on biodegradable vehicles, such as cerement and stimulan. However, existing randomised controlled trials (RCTs) are only reporting the use of non-absorbable polymethylmethacrylate impregnated cement in diabetic foot infection.

Lipsky et al reported the randomised use or non-use of a gentamicin-collagen sponge, in addition to standard care, for moderately infected foot ulcers in 38 DFU patients,11 which showed significant rates of clinical cure and eradication of baseline pathogens. In general, rates of wound-healing and re-operation were good in the papers that were reviewed, but long-term follow-up is required.

In conclusion, the role of topical antibiotic agents in treating diabetic foot infections is limited, and current use of antibiotic bone void fillers to protect resection margins and allow healthy regeneration is still in its infancy.

However, these processes may lead to early healing combined with off-loading.

Surgical exostectomy

In simple terms, this is the removal of material to achieve direct bony pressure offloading without providing definitive foot stabilisation. Current evidence suggests that medial exostectomy for offloading is a safe procedure. However, surgical decision-making needs an understanding of osseous or bony instability.

This is particularly the case for the lateral column (or outer border of the foot), which involves the cuboid. Some have noted early radiographic changes leading to a need to repeat exostectomy for ulcers under the lateral column of the foot.12

Surgical reconstruction (stabilising foot shape for sustained plantar pressure reduction)

These techniques are used in limb salvage involving deformity correction, with the aim of keeping the foot flat to the floor, and plantigrade without pressure areas for ambulation. These patients suffer from deformity associated with Charcot neuroarthropathy and may

Diabetic foot have vascular insufficiency, requiring combined surgical treatment. The amputation risk is seven times higher for patients with an ulcer and 12 times higher for patients with Charcot and an ulcer, compared with Charcot alone.13 Surgical reconstruction either with external fixation (frames) or specialised implants, such as disease-specific bolts and plates, shows much promise and results in single or own surgeon series are good, with low rates of re-ulceration and major complication, including amputations.14–19

multidisciplinary team management is key.

Recurrence after healing is a problem; we heal ulcers as quickly as possible to avoid early amputation and tissue loss due to secondary infection.

However, treatment strategies need to be progressive for long-term offloading, and we must consider surgical intervention to mechanically stabilise and harmonise the foot.

This may allow appropriate surgical decision-making to avoid recurrence but requires an improvement in our

From the current update, it is clear that fixed offloading devices have superior efficacy, but heel ulcers remain difficult to treat.”

This may be a process that is related to the level of medical care received after such surgeries, or ongoing follow-up within a multidisciplinary team. Even so, recent systematic reviews suggest limb salvage rates may in part be improving due to the continued development of superior implants. Therefore, Charcot foot reconstruction is likely to be a better alternative to lower limb amputation in selected cases.20

Summary

Sadly, the problem does not end with healing, and offloading as Buss et al reveal;4 there must be a shift in emphasis, as healed foot ulcers frequently recur.

This requires a collective refocus from acute offloading to long-term preventive offloading.

We still require standardisation of outcomes and measures of offloading, in addition to more highquality evidence concerning surgical offloading procedures. This will help us to determine the impact of surgical interventions on the healing of both noncomplicated and complicated foot ulcers.

Today, we are still learning more about harmonising and balancing the foot after surgery, as well as understanding resection margins of treatment to prevent ulceration.21 There is an increasing number of patients who now prefer to undergo limb salvage, fearing tissue loss more than life.22 Currently, there are no case-controlled studies or RCTs, but a number of metaanalyses confirm surgical efficacy from the results of what would be considered low-value studies.19 Formal case reporting in Charcot registries may be the next step then, as an RCT could have several ethical barriers that are quite difficult to overcome in this lowvolume arena.

Conclusion

From the current update, it is clear that fixed offloading devices have superior efficacy, but heel ulcers remain difficult to treat. The gold standard is still TCC, and all other fixed, non-removable offloading devices are judged against it; the exact offloading capability of each is not fully known, so ongoing

understanding of anatomical foot reconstruction in these patients, defining a time point when surgery could protect against irretrievable tissue loss primarily, but also prevent re-ulceration and allow function to be retained.

Further evaluation has to be conducted using the concepts of value-based healthcare,23 where reduction in the episode of ulceration, and recurrence, will become important outcomes—we may well see these concepts in the next guidelines to reflect a new mindset in outcomes.

References: 1. L azzarini PA, Crews RT, Van Netten JJ, Bus SA, Fernando ME, Chadwick PJ, et al. Measuring Plantar Tissue Stress in People with Diabetic Peripheral Neuropathy: A Critical Concept in Diabetic Foot Management. Journal of Diabetes Science and Technology. 2019; 0(0):1932296819849092.

2. F ernando ME, Crowther RG, Pappas E, Lazzarini PA, Cunningham M, Sangla KS, et al. Plantar pressure in diabetic peripheral neuropathy patients with active foot ulceration, previous ulceration and no history of ulceration: a meta- analysis of observational studies.

Plos One. 2014; 9(6):e99050.

3. F ernando M, Crowther R, Lazzarini P, Sangla K, Cunningham M, Buttner P, et al. Biomechanical characteristics of peripheral diabetic neuropathy: A systematic review and meta-analysis of findings from the gait cycle, muscle activity and dynamic barefoot plantar pressure. Clinical Biomechanics (Bristol, Avon). 2013; 28(8):831-45.

4. A rmstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. New England Journal of Medicine. 2017; 376(24):2367-75.

5. B us SA, van Deursen RW, Armstrong DG, Lewis JEA, Caravaggi CF, Cavanagh PR, et al. Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes/Metabolism Research and Reviews. 2016; 32:99-118.

6. S chaper NC, Van Netten JJ, Apelqvist J, Lipsky BA, Bakker K, on behalf of the International Working Group on the Diabetic F. Prevention and management of foot problems in diabetes: A Summary Guidance for Daily Practice 2015, based on the IWGDF Guidance Documents. Diabetes/Metabolism Research and Reviews. 2016; 32:7-15.

7. R eiber GE, Pecoraro RE, Koepsell TD. Risk factors for amputation in patients with diabetes mellitus. A casecontrol study. Ann Intern Med. 1992;117(2):97–105.

8. B us SA, Lavery LA, Monteiro-Soares M, Rasmussen A, Raspovic A, Sacco ICN, et al. IWGDF Guideline on the prevention of foot ulcers in persons with diabetes.

Diabetes/Metabolism Research & Reviews. 2019; in press.

9. B us SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlavácek P, et al. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes/Metabolism Research & Reviews. 2008; 24: S162-80.

10. M otamedi AK, Ansari M. Comparison of Metatarsal Head Resection Versus Conservative Care in Treatment of Neuropathic Diabetic Foot Ulcers. J Foot Ankle Surg. 2017; 56(3):428-33.

11. L ipsky BA, Kuss M, Edmonds M, Reyzelman A, Sigal F. Topical application of a gentamicin-collagen sponge com- bined with systemic antibiotic therapy for the treatment of diabetic foot infections of moderate severity: a randomized, controlled, multicenter clinical trial. J Am Podiatr Med Assoc.

2012; 102:223-232.

12. L aurinaviciene R, Kirketerp-Moeller K, Holstein PE. Exostectomy for chronic midfoot plantar ulcer in Charcot deformity. J Wound Care. 2008; 17:53-55.

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13. Sohn MW, Stuck RM, Pinzur M, Lee TA, BudimanMak E. Lower-Extremity Amputation Risk After Charcot Arthropathy and Diabetic Foot Ulcer.

Diabetes Care. 2010 Jan; 33(1):98-100. doi: 10.2337/dc09-1497.

14. Dayton P, Feilmeier M, Thompson M, Whitehouse P, Reimer RA. Comparison of Complications for Internal and External Fixation for Charcot Reconstruction: A Systematic Review. Foot Ankle Surg. 2015 Nov-Dec; 54(6):1072-5. doi: 10.1053/j. jfas.2015.06.003. Epub 2015 Jul 26.

15. Lee DJ, Schaffer J, Chen T, Oh I. Internal Versus External Fixation of Charcot Midfoot Deformity Realignment. Orthopedics. 2016 Jul 1;39(4):e595601. doi: 10.3928/01477447-20160526-11. Epub 2016 Jun 6.

16. Emara KM, Ahmed Diab R, Amr Hemida M. Tibiocalcaneal fusion by retrograde intramedullary nailing in charcot neuroarthropathy. Foot (Edinb). 2018 Mar;34:6-10. doi: 10.1016/j.foot.2017.11.003. Epub 2017 Nov 7.

17. Wiewiorski M1, Yasui T, Miska M, Frigg A, Valderrabano V. Solid bolt fixation of the medial column in Charcot midfoot arthropathy. J Foot Ankle Surg. 2013 Jan-Feb;52(1):88-94. doi: 10.1053/j. jfas.2012.05.017. Epub 2012 Aug 28.

18. N. Vasukutty*, H. Jawalkar, A. Anugraha, et al.

Correction of ankle and hind foot deformity in Charcot neuroarthropathy using a retrograde hind foot nail—The Kings’ Experience. http://dx.doi. org/10.1016/j.fas.2017.04.014 19. Shazadeh Safavi P, Jupiter DC, Panchbhavi V. A Systematic Review of Current Surgical Interventions for Charcot Neuroarthropathy of the Midfoot. J Foot Ankle Surg. 2017 Nov - Dec; 56(6):1249-1252. doi: 10.1053/j.jfas.2017.06.011. Epub 2017 Aug 1.

20. Dayton P, Feilmeier M, Thompson M, Whitehouse P, Reimer RA. Comparison of Complications for Internal and External Fixation for Charcot Reconstruction: A Systematic Review.

21. Suh YC, Kushida-Contreras BH, Suh HP, et al.

Is Reconstruction Preserving the First Ray or First Two Rays Better Than Full Transmetatarsal Amputation in Diabetic Foot? Plast Reconstr Surg. 2019 Jan; 143(1):294-305. doi: 10.1097/ PRS.0000000000005122.

22. Wukich DK, Sadoskas D, Vaudreuil NJ, Fourman M. Comparison of Diabetic Charcot Patients with and Without Foot Wounds. Foot Ankle Int. 2017 Feb; 38(2):140-148. doi: 10.1177/1071100716673985.

Epub 2016 Oct 24.

23. Porter ME, What Is Value in Health Care? N Engl J Med 2010; 363:2477-2481. DOI: 10.1056/ NEJMp1011024

Raju Ahluwalia is a full-time orthopaedic consultant foot and ankle surgeon at King’s College Hospital NHS Foundation Trust, London, UK, trained in London and Cambridge, and has undertaken advanced training at RNOH Stanmore and Oxford. He is an elected executive committee member of the Diabetic Foot Study Group of the European Association for the Study of Diabetes (EASD) and sits on the International Diabetic Foot Care Group.

Chris Manu is a consultant diabetologist and general medicine at King’s College Hospital NHS Foundation Trust and Bromley Healthcare, London, UK, with clinical and academic sub-speciality interest in the diabetic foot disease, and transformation lead for diabetic foot disease in south east London. He is a member of the International Diabetic Foot Care Group and part of the team developing the Fast Track Pathway.

Ines L Reichert completed a PhD in Fracture Healing and Bone Blood, and fellowships at St Michael’s Hospital, Toronto, Canada. She undertakes complex trauma and diabetic foot reconstruction. She has maintained an active interest in research and is a member of the British Orthopaedic Research Society. She also serves on the editorial board of Bone & Joint Research and is the orthopaedic and rheumatology research and development lead for clinical studies at King’s College Hospital NHS Foundation Trust, London, UK. The authors would like to acknowledge Michael Edmonds in developing ideas and preparation of the article.

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February 2020 | Issue 02

Diabetic foot

Sensory insole system for diabetic patients achieves reduction in recurrent ulcers Improvements that enable better miniaturisation of technology leads to higher-quality wearable health solutions, said Breanne Everett (Orpyx Medical Technologies, Calgary, Canada) at the American College of Wound Healing and Tissue Repair (ACWHTR; 11–12 October 2019, Chicago, USA).

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urthermore, new directions in reimbursement toward remote physiologic monitoring are enabling alignment of patient, provider, and payer incentives, she revealed. “With the right tools, providers can now be paid to deliver sustained, prevention-based wound management.”

Everett, a medical doctor and resident in plastic and reconstructive surgery at the University of Calgary, was delivering a presentation titled “Foot pressure dynamic management: changing the game”, in which she outlined the diabetes epidemic among North Americans and its impact on diabetic peripheral neuropathy.

In her talk, she pointed to the findings of a study on a sensory insole system developed by Orpyx—SurroSense Rx—where she is CEO and president.

Researchers sought to determine the device’s efficacy in reducing foot ulcer recurrence in high-risk patients, hypothesising that such a system would be effective in achieving a decrease.

The trial, “Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study”, was conducted by Caroline Abbott (Manchester Metropolitan University, Manchester, UK) et al and published in the October 2019 issue of The Lancet Digital Health.

During her presentation at ACWHTR, Everett set the scene: one in three North Americans are either diabetic or prediabetic; there are 1.7 million ulcers per year in the United States; 25% of people with diabetes develop ulcers during their lifetime; there are 120,000 lower extremity amputations per year.

In terms of cost, she emphasised that the direct cost of diabetes care is US$176 billion, with around US$60 billion related to limb care. Diabetic foot ulcers result in costs up to US$70,000 per event, with a median of US$15,200. Furthermore, the five-year mortality rate of a patient with a diabetic foot ulcer is 45%, which is higher than breast cancer and colon cancer rates.

“Current standard of care has not significantly improved diabetic foot ulcer recurrence rates over time,” Everett went on to say. “Once a patient’s wound has healed, there is a 49% chance they will re-ulcerate in the first year, which jumps to 65% within five years, and by year 10 almost all patients will have at least one additional ulcer in their lifetime. Because of this, we need to shift our thinking.

Often, once the wound is closed, we consider the patient healed and send them back to their normal activities. Instead, we need to consider these patients in remission and provide sustained, preventative care.”

The study aimed to investigate the effect of a sensory insole system in a real-life situation over 18 months. The technology would provide feedback when sustained low-magnitude plantar pressure occurs during harmful physical activities like prolonged sitting and standing in order to guide regular offloading, the authors of the trial noted.

Researchers recruited patients with diabetes, peripheral neuropathy, and a recent history of plantar foot ulceration from two multidisciplinary outpatient diabetic foot clinics in the UK, randomly assigning them to either an intervention or control group.

“All patients received an insole system, which measured plantar pressure continuously during daily life,” the authors wrote. “The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts.”

The primary outcome was plantar foot ulcer occurrence within 18 months, while a secondary outcome was adherence to wearing the device, along with exploratory outcomes of time to ulceration and callus severity. Between March 2014 and December 2016, some 90 patients signed up to take part, with 58 going on to complete the study.

At follow-up, 10 ulcers from 8,638 person-days were recorded in the control group and four ulcers from 11,835 person-days in the intervention group, the researchers found. Ultimately, there was “a 71% reduction in ulcer incidence in the intervention group compared with

With the right tools, providers can now be paid to deliver sustained, preventionbased wound management.”

the control group [IR: 0.29, 95% CI: 0.09–0∙93; p=0.037].”

Everett continued: “The number of patients who ulcerated was similar between groups (six of 26 [control group] vs. four of 32 [intervention group]; p=0.29); however, individual plantar sites ulcerated more often in the control group (10 of 416) than in the intervention group (four of 512; p=0.047). In an exploratory analysis of good compliers (n=40), defined as those that wore the system for at least 4.5 hours a day, ulcer incidence was reduced by 86% in the intervention group versus control group [IR: 0.14, 95% CI: 0.03–0.63; p=0.011].”

In the exploratory analysis, plantar callus severity—measuring the change from baseline to six months—was greater in re-ulcerating patients (callus severity score: 6.5, IQR 4.0–8.3) than non-reulcerating patients (2, 0–4.8; p=0.040).

The authors concluded: “To our

knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence.”

They further recommended that future randomised trials probe the efficacy and cost-effectiveness of the system in the wider diabetic at-risk neuropathic community for ulcer prevention.

Speaking to iWounds News, Everett highlighted efforts to prevent recurrence: “Since the study completion, we have focused on improving the functionality of the device to make it easier for the wearer by imbedding the sensors into a high-quality, custom insole,” stated Everett. “In addition to pressure sensing, the device can also monitor temperature, which is a late stage indicator of potential diabetic foot ulcer formation,” she added.

Breanne Everett

Trial results show three-fold reduction in diabetic foot ulcer size with pravibismane MICROBION CORPORATION HAS announced results from a phase 1b trial of its microbial bioenergetic inhibitor, pravibismane, in patients with moderate to severe infected diabetic foot ulcers (DFUs). The findings of the trial were presented at the Symposium on Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA).

“Topical pravibismane, or MBN-101, shows promise to improve outcomes and the quality of life of patients with chronic DFUs that are infected or colonised with bacteria,” said Paul Kim, professor at the Department of Plastic Surgery and Orthopedic Surgery, and medical director of the Wound Programme at William P Clements Jr University Hospital, Dallas, USA. He added: “The potential to prevent amputations and close wounds with pravibismane would be a significant benefit to patients and requires further study.”

The randomised, double-blinded, placebo-controlled phase 1b trial evaluated topically applied pravibismane (MBN-101) plus standard of care treatment, as compared to placebo plus standard of care treatment, in 52 patients with moderate to severe DFU infections. MBN-101 was well tolerated and no treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) occurring in the study were considered to be related to the study drug.

Although the study was not designed to demonstrate statistical efficacy, a numerical trend of greater median wound size reduction and reduced amputation rate with MBN-101 treatment was observed compared to placebo.

Furthermore, the median percentage reduction in ulcer wound size from baseline was approximately three-fold higher in the pooled MBN-101 group (85% wound size reduction) compared to placebo (29% wound size reduction) at end of study (defined as four weeks after end of treatment).

Target ulcer-related amputation rates in the pooled MBN-101 treatment groups were 2.6% versus 15.4% for placebo, an approximate six-fold reduction, and there was no evidence of either pravibismane systemic exposure or differences in resolution of infection signs and symptoms across treatment groups.

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February 2020 | Issue 02

Market watch comprehensive clinical body of evidence to validate the utility of SkinTE,” said Nikolai Sopko, chief scientific officer of PolarityTE.

Product News Pilot study confirms beneficial impact of SkinTE on closing venous ulcers

PolarityTE has announced findings from an open-label, single-arm pilot study, which examined the impact of SkinTE in closing venous leg ulcers (VLUs) following the failure of conventional treatments.

The clinical outcomes were reported in a poster presentation, titled “Pilot study assessing novel autologous homologous skin construct treatment of venous stasis leg ulcers”, at the Symposium on Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA).

“The completion of this pilot study is a pivotal step in further establishing SkinTE as a treatment for VLUs,” said study first author David Armstrong (Keck School of Medicine, University of Southern California, Los Angeles, USA).

He added: “As a clinician and researcher, study findings provide valuable learnings into real-world outcomes and offer the opportunity to broaden treatment options for healthcare providers and patients. We look forward to further data that build upon these initial results.”

The pilot study included 10 patients

with VLUs that remained open after at least one month of conventional treatments. The patients were treated with SkinTE, an autologous, homologous human cellular and tissuebased product designed to regenerate full-thickness, functional skin for the repair, reconstruction, and replacement of a patient’s own skin.

The study found an 80% closure rate of the VLUs within 12 weeks after treatment with SkinTE. In addition, all of the patients’ wounds demonstrated graft take and initial signs of closure, including granulation and progressive epithelialisation.

One VLU, which had previously been deemed closed, had reopened prior to the two-week durability visit as a result of external factors unrelated to the SkinTE procedure. Furthermore, another VLU did not close within 12 weeks, which was the largest in the study (12.2cm2) and had remained open for several months prior to treatment with SkinTE after previously failed treatment with a split-thickness skin graft; this VLU closed within 13.5 weeks postapplication of SkinTE. “We are pleased with the results of our VLU pilot study and this announcement further signifies the strides we are making to build a

Mobile app launched to optimise wound imaging and assessment

WoundVision, the manufacturer of the industry’s first long-wave infrared thermography (LWIT) solution for mitigating risks associated with hospitalacquired pressure injuries (HAPIs) and other wounds, has announced the expansion of its product offering with the debut of the Scout Mobile app.

Built to streamline and simplify wound documentation, Scout Mobile is said to be an enterprise mobile wound management app that standardises wound photography, measurement, and assessment across the entire healthcare continuum. With multiplatform support for both iOS and Android smartphones and tablets, the solution also eliminates the inaccuracies of paper rulers and fulfils minimum documentation requirements while seamlessly integrating into electronic medical record (EMR) workflows.

With the addition of a mobile app to their existing Scout product suite, WoundVision becomes the industry’s first provider of wound imaging and documentation solutions. Positioned as the healthcare industry’s one-stopshop for all digital wound management needs, this solution is comprised of the Scout multimodal imaging device

(photographic and thermographic), the Scout Software, electronic medical record (EMR) integration and the Scout Mobile app. Providers now have access to a range of solutions, which includes: The industry’s only anatomical and physiological imaging solution to identify deep tissue pressure injury (DTPI) present on admission (POA) A mobile imaging app for wound photography, measurement and assessment across the entire continuum of care An enterprise software solution that standardises all POA documentation and wound measurement and assessment Seamless EMR integration into existing clinical workflows “In a market that is saturated with

WoundVision

Issue 02 | February 2020

Market watch

Product News mobile wound photography apps and other single-capability products, Scout Mobile ties all of our solutions together, positioning us as the industry’s only full-service wound imaging and documentation solution,” said James G Spahn, co-founder and CEO of WoundVision.

Retrospective study finds Kerecis fish-skin graft to be effective for diabetic wound treatment

The efficacy of the Kerecis fish skin treatment for diabetic lower-extremity wounds has been affirmed in a new peer-reviewed article published in the journal Wounds.

The paper, “Acellular fish skin graft use for diabetic lower extremity wound healing: A retrospective study of 58 ulcerations and a literature review”, was co-authored by Shannon Michael (St Vincent Hospital, Indianapolis, USA; Food & Ankle Clinics of Arizona, Chandler, USA); Christopher Winters (American Health Network, St Vincent Hospital, Indianapolis, USA); and Maliha Khan (St Vincent Hospital, Indianapolis, USA).

According to a statement, the threeyear retrospective study evaluated the efficacy of the Kerecis Omega3 rich fish skin used as a graft in the treatment of full-thickness diabetic foot ulcers. In the trial, the fish skin was used to treat 51 patients with a total of 58 wounds. The investigator then compared the initial wound surface area with the final wound surface area to calculate the percentage of the total wounds that healed over a 16-week treatment period.

The trial found that there was “a mean reduction of wound surface area by 87.6% and 35 wounds (over 60%) were fully healed”. In addition to the treatment, the authors reviewed 10 articles about fish skin grafts, three of which specifically evaluated lower extremity ulcers.

Overall, the authors concluded that the study supports increased wound healing rates with the use of fish skin grafts for the treatment of diabetic wounds. Furthermore, rapid woundsurface-area reduction during the initial four weeks following graft application validates previous research that fish skin grafts enable diabetic wounds to transition from a chronic inflammatory stage to an acute wound environment for healing.

Cost-benefit analysis highlights potential of haemoglobin spray for improving chronic wound care

A controlled evaluation of 100 UK National Health Service (NHS) patients has demonstrated savings in chronic wound care costs with the use of Granulox, a haemoglobin spray that

binds oxygen from the atmosphere and facilitates its diffusion to the wound bed (used as adjunct to standard wound care therapy).

The analysis highlighted that Granulox pays for itself in terms of cost-savings as soon as eight weeks into treatment based on reduced healing times and therefore reduced need for consumables.

The evaluation “Cost-effectiveness of adjunct haemoglobin spray in the treatment of hard-to-heal wounds in a UK NHS primary care setting” has been published in the Journal of Wound Care.

It followed 50 consecutive patients treated with Granulox as an adjunct to standard care (intervention group —dressing changes completed by patient and/or carer) over 26 weeks, and compared their wound healing process against 50 consecutive retrospective controls treated with standard care only (control group—dressing changes completed by healthcare professionals), in the same clinic, in the year before the introduction of Granulox.

Patients in the intervention group received Granulox application with each dressing change and in line with the manufacturer’s instruction for use. Cost savings were calculated against actual costs of consumables. In the evaluation, the hard-to-heal wounds included pressure ulcers, leg ulcers or diabetic foot ulcers, as well as burns, surgical and trauma wounds that had failed to heal normally.

A cost-effectiveness and breakeven analysis of the clinical results demonstrated that at eight weeks enough dressing costs are saved to pay for treatment with Granulox, making it a cost-effective solution in chronic wound care management (before calculating the benefit of reduced cost of clinician time saving). There was an average saving of £82 on dressings per patient at 26 weeks. At break-even point, the cost of dressings for patients treated with Granulox was £140 compared to £221 for patients treated in the control group.

“The impact of non-healing wounds on a patient’s quality of life can be devastating,” said Duncan Stang, podiatrist and National Diabetes Foot Coordinator for Scotland.

“The ability to help these patients without a financial burden to the NHS, and in fact demonstrated cost savings, is an invaluable opportunity. The analysis does demonstrate cost-effectiveness— which is excellent—and what is also really interesting about this work is the reduced healing times: benefitting patients and of course healthcare teams who are working in an ever stretched NHS, particularly in wound care.”

At 20 weeks, 90% of wounds treated with Granulox healed. The analysis calculated that for Granulox to pay for itself it would need to be effective on 72% of patients. Without the

haemoglobin spray, in the control group, half of the patients were still not healed in over six months.

This publication adds to previous cost-effectiveness evidence of Granulox, published by Health Improvement Scotland, which reported expected average cost savings of £2,330 per patient in diabetic foot ulcers, £1,469 per patient in chronic wounds, and £849 per patient in sloughy wounds over six months.

This evaluation estimated total cost-effectiveness not only on dressing costs. Dressing materials and nurse time were included in the analysis, as well as surgical procedures related to chronic wounds including surgical debridement and amputation.

Wound care management is costly for the NHS. A retrospective cohort analysis data from The Health Improvement Network estimated that the NHS treats more than two million patients annually in the UK at a cost of £4.5–£5.1 billion at 2012/2013 prices. Over a third (39%) of these wounds were not healed within the study period and the costs of treating them ranged from £1,719 to £5,976 per patient.

Fluorescence imaging device from MolecuLight wins AMA approval

MolecuLight has been informed by the American Medical Association (AMA) that in its summary of panel actions September 2019 meeting, the Current Procedural Terminology (CPT) Editorial Panel accepted the addition of new Category III codes 0X30T, 0X31T to report “wound bacterial localisation and treatment” effective, 1 July 2020, enabling a reimbursement pathway for point-of-care fluorescence wound imaging.

At that time, a novel code excluding the “X” will be reported by the AMA when the final data files are distributed. Point-of-care fluorescence wound imaging is achieved using MolecuLight’s handheld fluorescence imaging device, the i:X. “In working to heal wounds, we have been flying with the equivalent of a stick and rudder—and sometimes that means flying blind,” said David Armstrong, professor of surgery and director of the Southwestern Academic Limb Salvage Alliance (SALSA) at the Keck School of Medicine, University of Southern California, USA. “Advanced technologies such as this one can ultimately serve to make physicians, surgeons and nurses ‘instrument-rated’ to not only heal people faster, but also to reduce risks for infections, hospitalisations and amputations. The fact that the procedure is being recognised with a new pathway to reimbursement by the AMA is very exciting, as we might now be able to measure what we manage,” he said.

Category III CPT codes are temporary codes for emerging technologies and procedures that allow for specific data collection associated with the work and costs of the procedures. Reimbursement for procedures reported with a Category

21

III code is at the payer’s discretion.

As these procedures become more commonly adopted and established, MolecuLight will continue to work with the AMA to move these codes from Category III to Category I CPT status.

Certain elements of the procedure’s description and details of the code may be subject to change and will be finalised upon formal issuance of the Category III code.

First CLTI patient enrolled in PROMISE II pivotal study of LimFlow system

LimFlow has announced that the first patient has been treated as part of PROMISE II, a US-based pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.

The successful first case was performed by Mark Archie (HarborUCLA Medical Center, Los Angeles, USA), principal investigator for the PROMISE II trial, and Nina Bowens (Harbor-UCLA Medical Center, Los Angeles, USA), subinvestigator for the PROMISE II trial.

“We are pleased to be the first centre in the country to treat a patient in this important trial,” said Archie. “The LimFlow system offers a promising new therapy with the potential to restore blood flow to the ischaemic foot, heal wounds, and prevent major amputations in a patient population that is unable at the moment to be treated with any current technology”.

PROMISE II is a multicentre, prospective, single-arm study that will be conducted in the USA and Japan.

Using an adaptive statistical design, the study plans to enrol 60 to 120 “no option” chronic limb-threatening ischaemia (CLTI) patients. Endpoints include amputation-free survival at six months, limb salvage, and wound healing. Subjects will be followed up out to three years. The “no option” patients who are candidates for the PROMISE II study are no longer eligible for conventional endovascular or surgical therapy for CLTI, as determined by an independent physician committee.

When all other therapeutic options have been exhausted and a CLTI patient is facing major amputation, the minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing and prevents major amputation.

Patients with CLTI often experience profound, chronic pain and develop festering wounds or infections that lead to major limb amputation, an event closely associated with increased mortality and reduced quality of life.

To relieve the symptoms of CLTI, patients today are treated primarily with angioplasty or open bypass surgery. In many late-stage patients, however, neither of these treatment options are feasible due to extensive disease in the target arteries or other anatomical constraints.

22

February 2020 | Issue 02

Market watch

Parliamentary group report raises awareness of difficulties with venous leg ulcers

Industry News 3M finalises $6.7 billion acquisition of Acelity

3M has announced that it has completed the acquisition of Acelity and its KCI subsidiaries from a consortium comprised of funds advised by Apax Partners (the Apax Funds), together with controlled affiliates of the Canada Pension Plan Investment Board (CPPIB) and the Public Sector Pension Investment Board (PSP Investments).

Acquired for a total enterprise value of approximately $6.7 billion, including the assumption of debt and other adjustments, Acelity is a leading global medical technology company focused on advanced wound care and applications marketed under the KCI brand.

“This is an exciting day as we bring together two premier and innovative companies that are focused on delivering comprehensive health care solutions to enable better outcomes for patients,” said 3M chairman and CEO Mike Roman.

“We are excited to have the tremendous people of Acelity join the 3M team, and are confident in the value that this acquisition will deliver to our customers and our shareholders. This addition further accelerates 3M as a

leader in advanced wound care, which is a significant and growing market segment.”

3M’s Medical Solutions business is said to be focused on applying 3M technologies to deliver safe and effective solutions to improve clinical outcomes and health economics. The business also offers a range of integrated solutions that include advanced and acute wound care dressings and products, medical tapes, sterilisation products, and patient prep and warming products.

According to a statement, these solutions cross the entire continuum of care, enabling better outcomes, improving the patient experience, and delivering strong economic value in today’s value-based care environment.

The Acelity business is well known for creating and growing new segments based on the ability to identify and address unmet clinical needs with KCI-branded products that advance the practice of medicine, beginning with the introduction of V.A.C. Therapy: groundbreaking Negative Pressure Wound Therapy (NPWT). Furthermore, KCI product offerings also include advanced wound dressings and negative pressure surgical solutions.

A report titled “Venous Leg Ulcers: A Silent Crisis” has been published by the All-Party Parliamentary Group on Vascular and Venous Disease (VVAPPG) at an event held at the Palace of Westminster, highlighting the opportunities available to help thousands of patients suffering with painful leg ulcers.

Over 200,000 people in the UK are known to suffer from venous leg ulcers (VLUs), which are extremely painful, malodorous, require constant attention, and are highly disruptive to people’s lives.

For most patients, the treatment options made available offer the chance to manage the ulcer, which is just the symptom, rather than addressing the underlying health issues that cause it.

This is despite surgical options being available to treat the underlying health issues and promote faster healing rates, a cost-effective approach which could significantly improve lives.

Furthermore, evidence suggests that the UK spends up to £1.3 billion per year in managing VLUs. Around 64% of clinical commissioning groups’ commissioning policies were found to be non-compliant with NICE guidance and 75% of all VLUs do not receive a comprehensive vascular assessment, as

enshrined in NICE guidance.

Evidence also shows that a health postcode lottery exists, whereby a patient’s entire experience may show significant variation depending simply on where they live.

In response to this crisis, the VVAPPG launched its first report on VLUs on 15 October at the Palace of Westminster. The report aims to raise awareness on this subject and makes recommendations to deliver better health outcomes.

Derek Thomas MP, chair of the VVAPPG, said: “Every year thousands of patients are being failed by poor treatment pathways and misdiagnosis. What is worse is that so many doctors and vascular experts agree on what needs to change and how to do it.”

He added: “With this report, we want to raise awareness on this issue and point out that cost-effective medical solutions are available. It’s about saying, let’s get on and drive change to help thousands live without pain.”

Calendar of events 20 February National Wound Care Conference London, UK

27–28 February NPUAP: National Pressure Ulcer Advisory Panel Houston, USA

8–12 March WUWHS: World Union of Wound Healing Societies Abu Dhabi, UAEE

www.jwcconference.com

www.npuap.org

www.wuwhs.com

26–27 February Wound Care Today Milton Keynes, UK

3–6 March AVF: American Venous Forum Amelia Island, USA

26–28 March AAWC Pressure Ulcer Summit Atlanta, USA

www.woundcare-today.com

www.veinforum.org

www.aawcsummits.com

October 2019 Michael

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| Issue 01

Edmonds:

Diabetic foot A new era

care: Page 6

Profile

21–24 April iWounds at CX Symposium London, UK www.cxsymposium.com

www.ewma.org

13–17 May SAWC Spring: Symposium on Advanced Care San Diego, USA www.sawcspring.com

iWounds News is an independent source of news and opinion in the wound care world.

Page 12

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www.woundweek2020.sched.com

13–15 May EWMA: European Wound Management Association London, UK

William Ennis:

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16–19 April APWCA Wound Week: American Professional Wound Care Association Milwaukee, USA

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