First Shock Wave Device FDA-Cleared for Diabetic Foot Ulcers

The study was supported by data from studies involving 336 patients
The study was supported by data from studies involving 336 patients

The Food and Drug Administration (FDA) has granted marketing clearance of the Dermapace System (Saunwave, Inc.), the first shock wave device intended to treat diabetic foot ulcers.

The Dermapace System is intended for use in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas up to 16cm2 in patients aged ≥22 years, presenting with diabetic foot ulcers lasting over 30 days. The extracorporeal shock wave system uses energy pulses to stimulate the wound and should be used with standard diabetic ulcer care. 

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The approval was supported by data from 2 multicenter, randomized, double-blind studies involving 336 patients receiving either usual care (wet-to-dry dressings or debridement) as needed plus the Dermapace System therapy or usual care with a sham shock wave therapy. 

Data showed patients who received 1 to 7 treatment with the Dermapace System had an increase in wound healing at 24 weeks with a 44% wound closure rate, as compared with a 30% wound closure rate among patients who received the sham shock wave therapy. 

Pain during device application, local bruising and numbness, migraines, nausea, fainting, wound infection, cellulitis, osteomyelitis, and fever were among the most commonly seen side effects. 

For more information visit FDA.gov.