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dermaPACE® System

dermaPACE® is the only FDA cleared or approved ESWT device to treat diabetic foot ulcers

dermaPACE® Scientific Literature
 

Clinical Support and Device Description

The dermaPACE® is the only FDA cleared focused electro-hydraulic extracorporeal shockwave device to treat diabetic foot ulcers, using a specific deployment of the acoustic shockwave technology to the wound care segment offering an improved non-invasive standard of care that may shorten an otherwise lengthy healing process. The dermaPACE® may improve patient quality of life when conservative therapy is not effective, as well as provide a cost savings to the health care system.

The dermaPACE®, in two double-blind, randomized, sham-controlled parallel group FDA clinical trials, without physician assisted closure and with only standard of care, performed at clinical sites in the U.S. and Europe (SAN07 and SAN12 Trials) n=336 showed the following:

  • dermaPACE® demonstrated superior results in 100% wound closure at 24 weeks compared to the control (37.79% vs. 26.22%; p=0.023, respectively)

    Figure 1

  • dermaPACE® demonstrated superior results in the prevention of wound expansion (≥ 10% increase in wound size) at 6 weeks (14.5% versus 26.2%; p=0.008, respectively)

  • While there are some differences in the success rates of certain demographic subpopulations, all statistically significant differences are in favor of dermaPACE®

  • dermaPACE® demonstrated a relatively low 2.3% rate of full target ulcer amputations.

  • Importantly, there were no meaningful statistical differences in the adverse event rates between the dermaPACE® patients and the sham-control group. There were no issues regarding the tolerability of the treatment which suggests that a second course of treatment, if needed, is a clinically viable option.

  • Premier Shockwave, Inc. is the largest orthopaedic and podiatric shockwave company in the United States and has been selected by SANUWAVE Health, Inc. as the distributor to the Veterans Health Administration, Indian Health Service, and military treatment facilities throughout the United States.

Biological Effects From Pulsed Acoustic Cellular Expression (PACE)

  • Published literature documents the biological responses(1) attributed to PACE application in both animal/benchtop studies and in humans. This evidence suggests that PACE treatments provide the necessary impetus to restart the body’s natural healing process by numerous means:

    • Initial response to the PACE application promotes microcirculatory improvement

    • Continued effects after treatment include modulation of inflammatory responses and perfusion response, an increase in capillary perfusion and vessel permeability; cellular signalling that initiates antigenic growth factor and protein upregulation

    • A further inflammatory response that activates vessel endothelial cells and initiates proangiogenic growth factor production leading to new vascularization

As a result, a chronic condition is now returned to an acute condition, jumpstarting the body’s own healing response and leading to wound area reduction and potentially complete wound healing.

ESWT v. HBOT Treating Diabetic Foot Ulcers

FIG 1 - Microscopic feathers of the histopathological examination before and after treatment:

  1. Considerably higher cell proliferation, cell concentration and cell activity, and lower cell apoptosis after ESWT (40T)

  2. Lower cell proliferation, cell concentration and cell activity, and higher cell apoptosis after HBOT(40T).  

FIG 2 - Blood flow perfusion scan of the lower limb before and after treatment:

  1. Poor blood perfusion before ESWT, and significant increase in blood perfusion rate after ESWT. ESWT (n=44) average value increased from 0.48 to 0.61 (p<0.001) an increase of ~ 27%

  2. Poor blood perfusion before HBOT, and unchanged blood flow perfusion rate after HBOT. HBOT (n=40) average value decreased from 0.59 to 0.50 (p 0.916).

Conclusion: ESWT is more effective than HBOT in chronic diabetic foot ulcers. ESWT-treated ulcers showed significant improvement in blood flow perfusion rate and cell activity leading to better healing of the ulcers relative to HBOT in chronic diabetic foot ulcers.

Procedure performed at time of weekly wound dressing change, can be administered with current standard of care; 6-8 minutes total procedure/clean-up time.

Clinical Practice

dermaPACE® Dosage

  • The standard dosage for treating wounds in the US Phase III trials was 500 pulses per treatment for a wound with a surface area < 64 cm2. A standard formula of 8 pulses/cm2 was applied for wound area sizes greater than 64 cm2. Based upon the results of the two trials, especially when analyzing subgroup response to treatment, SANUWAVE recommends an escalating number of shocks per treatment, based upon wound size as simply measured per the following table:

    Figure 2

  • There is no safety reason to limit the number of treatments; however, a minimum of 4 treatments should be delivered at a minimum of 48 hours apart and no later than 2 weeks apart.

  • There is no need for local or general anesthesia for most indications. Clinical evidence indicates that the device is well tolerated by patients.

  1. All citations can be found in the 46-page dermaPACE® System: Clinical Support and Device Description, available upon request from info@premiershockwave.com.