FDA Approves Marketing for Diabetic Foot Ulcers Shock Wave Therapy

The US Food and Drug Administration (FDA) has approved marketing for the Dermapace System, the first device designed to treat diabetic foot ulcers with shock wave technology.

The device, from Sanuwave Health, was previously approved outside of the US for advanced wound care indications, according to the manufacturing company. Its FDA indication is for the treatment of chronic, full-thickness diabetic foot ulcers, with wound areas measuring no larger than 16 cm², but without bone exposure.

Dermapace functions through external shock wave pulses that mechanically stimulate patients’ wounds. It is intended as a supplemental therapy for adult patients at least 22 years old, with diabetic foot ulcers lasting for more than 30 days.

The device was backed by clinical results from 2 multi-center, randomized, double-blind trials featuring 336 patients with diabetes. Patients received either usual care for ulcers (wet-to-dry dressings or debridement) as needed plus the Dermapace System therapy, or usual care plus a non-working shock wave therapy.

The patients to undergo between 1 and 7 treatments with Dermapace reported an increase in wound healing at 24 weeks, with a 44% wound closure rate. Patients treated with non-working shock wave therapy reported a 30% wound closure rate at the same time period.

Adverse effects commonly observed included pain from device application, local bruising and numbness, migraines, nausea, fainting, wound infection, cellulitis, osteomyelitis, and fever.

In the growing population of patients with diabetes (with 30.3 million in the US alone) about 25% will experience a foot ulcer in their lifetime. Diabetes can cause blood vessel and nerve damage, particular in the feet, which leads to difficult-to-treat infections. Amputations can become necessary when circulation is poor due to a foot ulcer or untreated infection.

Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said that diabetes is the leading cause of lower limb amputations.

“The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases,” Ashar said. “Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

The FDA approved Dermapace System through its de novo premarket review pathway, designated for low-to-moderate-risk devices of a new type which have no substantial equivalence to other marketed devices.