Masterclass Guides: Extracorporeal Shockwave Therapy: dermaPACE®

September - October 2022

GUIDES

Introduction

This Masterclass Guide is a concise overview exploring the modality of extracorporeal shockwave therapy and how to incorporate this into your clinical practice.

High-energy, nonthermal acoustic pressure waves generated via an electric discharge inside a fluid, which is known as the electrohydraulic method, is used.

Specially modulated shockwaves are delivered directly beyond the wound bed and periulcer area. Energy penetrates deep into and beyond the wound bed to the micro-vascular level where the problem originates, to stimulate perfusion and promote arteriogenesis and angiogenesis and form a new capilary network in the pathology of healing and wound closure.

The dermaPACE® system noninvasively delivers focused extracorporeal shockwaves that stimulate biological responses at the cellular level via mechanical stressing of tissue.

PACE® technology elicits the following responses:

■ Increased perfusion

■ Growth factor upregulation

What Is dermaPACE®?1

■ Inflammatory modulation

■ Angiogenesis

Keywords

Extracorporeal Shockwave Therapy: dermaPACE®

■ Extracorporeal Shockwave Therapy

■ Diabetic foot ulcer (DFU)

■ dermaPACE®

■ Wound

■ Wounds

■ Wound closure

■ Chronic wounds

■ Beyond the Wound Bed

■ Perfusion

■ Micro-vascular level

■ Extracorporeal Shockwave Technology (ESWT) utilizes high energy focused acoustic shockwaves created through an electrohydraulic method to treat chronic wounds

■ Energy stimulates cells, which starts cellular intercommunication resulting in expression of multiple healing factors

■ The dermaPACE® System is the first shockwave technology cleared by the FDA in the USA for treatment of Diabetic Foot Ulcers (DFU) only

■ The dermaPACE® System is used for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures

■ One treatment session typically lasts 5-7 minutes and fits in with the normal wound care routine in the physician’s office

■ It is non-invasive and well tolerated

■ Reach Beyond the Wound Bed to the micro-vascular level to establish a new capillarity network resulting in a wound healing process

■ Works with Standard of Care or alone

How dermaPACE® Works: The Ten Point Guide

1 Choose an appropriate patient

2 Prepare the wound bed according to Best Practice Guidelines

3 Use the intuitive screen to program the treatment settings

4 Apply the gel to the applicator head and the wound bed

5 The gel will allow high energy PACE® waves to penetrate the tissue as a coupling medium

6 Move the probe slowly and continuously across the surface of ulcer and periwound

7 Perform wound assessment before each treatment session, documenting the observations

8 Possible side effects can include reddening of wound, tingling and numbness

9 Remove the gel and apply standard dressing

10 Confirm treatment frequency regime with patient (Typically 1 treatment per week)

Figure 1: Application of dermaPACE® Treatment

Extracorporeal Shockwave Therapy: dermaPACE®

What Types of Wounds Are Suitable?

■ dermaPACE® is cleared by FDA for the treatment of Diabetic Foot Ulcers (DFU)

■ Deep, partial-thickness burns

■ Decubitus ulcers (pressure ulcers)

■ Venous ulcers

■ Burns and scalds

■ Trauma wounds

■ Surgical wounds

■ Skin conditions

DermaPACE® Is Used With Guidance and Caution in These Circumstances:

■ Children

■ Pregnancies

■ Malignancies

■ Coagulation disorders

Figure 2a: Pre-treatment

Figure 2b: Post-treatment (4 sessions)

Masterclass

GUIDES

What Is the Evidence?

Despite the development of advanced wound care products, there is still a need to find the most effective treatment for reducing the time required to close a wound.

The Noninvasive Extracorporeal Shockwave Therapy system, dermaPACE®, shows well evidenced improvements in wound area reduction, financial viability when compared to other costly alternatives, and ease of use with minimal training required.

Efficacy

■ Clinically proven to manage and heal wounds at greater rates and frequency than standard of care alone. The dermaPACE® system’s treatments can be used in combination with other treatment modalities, without causing any negative interference

■ dermaPACE® demonstrated superiority in wound healing and wound area reduction, with an excellent safety profile. When compared to the control, superior results were achieved4:

■ A greater number of DFUs treated with dermaPACE® healed (37.79%), as compared to DFUs treated with only standard of care (26.2%). These results were statistically significant beginning at 20 weeks to 24 weeks

■ DFUs treated with dermaPACE® reached closure at a faster rate than DFUs only treated with standard of care

■ Beginning at 4 weeks, the dermaPACE® group had a higher percentage of subjects with a 50% wound reduction compared to the control (p=0.058). This advantage for dermaPACE® continued throughout the remainder of the trial

Ease of Use

■ Banasiewicz and Cioanta note the ease of administration of the device, remarking how the noninvasive therapy was well tolerated by patients, and that a higher dosage has better results2

■ “We have been involved with dermaPACE® since 2012 after being part of the pivotal trial that demonstrated its utility in speeding wounds to closure. Since that time we have used the device extensively, with tremendously positive results not only in diabetic wound healing and closure but also incision line annealing, peri-wound edema reduction, pyoderma gangrenosum and adjunct treatment of osteomyelitis. We believe that these uses represent just the tip of the iceberg for dermaPACE®.”

■ “Results using SANUWAVE’s dermaPACE System have been very positive in treating diabetic foot ulcers. We put dermaPACE to use on complex DFUs that have not responded to the best practice applied to wounds longer than six months with a marked improvement. I highly recommend that you add this device to all advanced wound centers.”

■ “With the dermaPACE system, all of our diabetic foot ulcer patients that have completed six to 10 weeks of treatment have 100% healed. All patients had ABIs above 0.5 or had no peripheral ischemia with lower limb threatening disease.”

Larry Lodico, Clinical Services Director, The Wound Care Clinic of South Jersey

■ “In a patient with diabetes, we normally have decreased blood flow to the foot. This decreased blood flow starves the tissues and causes a skin breakdown and ulcerations. By applying this dermaPACE technology, we stimulate blood flow to these starved areas. When my patients were randomized in the study, we saw a remarkable rate of closure.”

Dr Brian Harper, Clinical Director, York Medical

Dr Peter P Balingit, LA County Dept. of Health Services

Dr. Perry V Mayer, The Mayer Institute (TMI), Hamilton Ontario, Canada

Extracorporeal Shockwave Therapy: dermaPACE®

Key Points

■ Simple and effective to use

■ No statistically significant adverse effects

■ Well tolerated by patients

■ The first shockwave system cleared by the FDA, for the treatment of diabetic foot ulcers (DFU) only, in the US

■ dermaPACE® is for the repair and regeneration of skin, musculoskeletal tissue and vascular structures, outside the US

References

1. Jumpstart Wound Healing. An Advanced Non-Invasive Wound Healing Technology. SANUWAVE, 2022 [Internet]. https://tinyurl.com/25kr82se [accessed 05/03/2021].

2. Banasiewicz T, Cioanta I. A Pilot Study to Determine the Effect of Different Dosage Regimens of High Energy Acoustic Shockwaves in Treating Diabetic Foot Ulcers. 2019. [Internet]. Available from https://tinyurl.com/55hkd6nn. [Accessed 26/08/2022].

3. Harper B. ESWT - PACE® Technology Utilizes High-Energy Acoustic Pressure Shockwaves to Produce Compressive and Tensile Stresses on Cells/Tissue Structures with Ultimate Goal of Regenerating Healthy Tissue In Chronic Foot Ulcers in a Community Clinical Setting. 2019. [Internet]. Available from https://tinyurl.com/456wzacj. [Accessed 26/08/2022].

4. Clinical Reference: (US IDE G070103);

5. The dermaPACE System Acoustic Wave Therapy for Advanced Wound Care and How It Works. SANUWAVE. 2022 [Internet]. https://sanuwave.com/our-technology/the-dermapace-system/ [accessed 05/03/2021].

6. Miller C,Kapp S, Green, J, McGuiness W, Woodward M.“Treating venous leg ulcers with extracorporeal shockwave therapy: A case series”. Wounds International, 2017, 8(3), 22-28.

7. Cole W, Coe S. Using a Non-Invasive Pulsed Acoustic Cellular Expression System to Promote Angiogenesis in Chronic Wounds. Presented at Symposium on Advanced Wound Care, 2019. Available from https://tinyurl.com/3j3busdu. [Accessed 26/08/2022].

8. Lee SY, Joo SY, Cho YS, Hur GY, Seo CH. Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study. Burns. 2021 Jun;47(4):821-827. doi: 10.1016/j.burns.2020.08.009. Epub 2020 Aug 29. PMID: 32917473.

9. dermaPACE. Technological Advancement in Wound Care. SANUWAVE, 2022 [Internet]. https://tinyurl.com/37xks6jw [accessed 05/03/2021].

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