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# Sanuwave De Novo Petition for Diabetic Foot Ulcer Device
- URL: https://www.fdaweb.com/sanuwave-de-novo-petition-for-diabetic-foot-ulcer-device/
- Published: 2016-08-11T12:00:00.000Z
- Updated: 2026-09-14T21:23:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136488

Sanuwave Health has submitted a *de novo* petition requesting CDRH review and classification of the dermaPACE System for treating diabetic foot ulcers as a Class 2 device. The submission is based on data from two clinical trials involving 336 patients. The trial’s primary endpoint was wound closure, which was defined as “successful” if the skin was 100% re-epithelialized at 12 weeks without drainage or dressing requirements confirmed at two consecutive study visits. Data showed patients treated with dermaPACE showed a “strong positive trend in the primary endpoint” and it “increased the proportion of diabetic foot ulcers that closed within 12 weeks,” the company says. At the 24-week secondary endpoint, the rate of wound closure in the dermaPACE cohort was 37.8% compared to 26.2% for the control group, it adds.