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FDA Approves Shock Wave Therapy Device for Diabetic Foot Ulcers

 6 months ago       163 Views

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

The device was backed by clinical results from 2 multicenter, 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.

Those patients who received between 1 and 7 treatments with Dermapace reported an increase in wound healing at 24 weeks, with a 44% wound closure rate.

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 United States alone) about 25% will experience a foot ulcer in their lifetime.

Diabetes can cause blood vessel and nerve damage, in the feet, which leads to difficult-to-treat infections.

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.

An earlier version of this article originally appeared on MDMagazine.com.

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Author: @DailyCupofYoga

Source: contagionlive.com