dermaPACE Has Been Clinically Validated by Thousands of Patients and Healthcare Providers


Clinical Results1,2

A 336-subject randomized and double-blind clinical trial investigating the effect of dermaPACE Shockwave treatment on Diabetic Foot Ulcers demonstrated superiority in wound healing and wound area reduction when comparing the dermaPACE System treated patients against the control patients, with an excellent safety profile. The dermaPACE System showed superior results vs. control:

  • In wound closure at 24 weeks (37.79% vs. 26.22%; p=0.023)
  • In the overall rate to wound closure (p=0.0346)
  • In the reduction in area (cm2) of the wound at six weeks (p=0.003) through 24 weeks (p=0.047)

Indications

The dermaPACE System is indicated in the US for the treatment of chronic Diabetic Foot Ulcers when used in conjunction with standard of care (de novo DEN160037).

Footnotes for Page

1. Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials. Snyder R, Galiano R, Mayer P, Rogers LC, Alvarez O, Sanuwave Trial Investigators. J Wound Care. 2018;27(12):822-836. doi:10.12968/jowc.2018.27.12.822
2. Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials, Galiano R, Snyder R, Mayer P, Rogers LC, Alvarez O, Sanuwave Trial Investigators. J Wound Care. 2019;28(6)
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