FDA OKs Device for Diabetic Foot Ulcer Treatment

Miriam E. Tucker


December 28, 2017

The US Food and Drug Administration (FDA) has permitted marketing of the first shock-wave device for treating diabetic foot ulcers.

The dermaPACE system (Sanuwave Inc) is an extracorporeal shock-wave system that uses energy pulses to mechanically stimulate wounds. It is intended for adults aged 22 years and older with chronic (>30 days), full-thickness diabetic foot ulcers that are no larger than 16 cm2; extend through the epidermis, dermis, tendon, or capsule; but do not involve bone exposure. The product is to be used in conjunction with standard diabetic ulcer care.

Data supporting the FDA approval came from two multicenter, randomized, double-blind clinical trials that included a total of 336 patients with well-controlled or poorly controlled diabetes and foot ulcers. All received standard wet-to-dry dressings or debridement and were randomly assigned to receive the dermaPACE system treatment or sham shock waves.

Wound closure rates at 24 weeks following one to seven treatments were 44% with the dermaPACE system compared with 30% with the sham therapy.

The most common side effects were pain during device application, local bruising and numbness, migraines, nausea, fainting, wound infection, cellulitis/osteomyelitis, and fever.

The FDA reviewed the dermaPACE system through its "de novo" premarket review pathway, which addresses low- to moderate-risk devices for which there is no already-marketed device to use for comparison. Now, future similar devices will be able to go through the 510(k) process to demonstrate substantial equivalence to this novel product.

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