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News From the Food and Drug Administration
February 20, 2018

Diabetic Foot Ulcers Heal With Shock Wave Therapy

JAMA. 2018;319(7):649. doi:10.1001/jama.2018.0480

The FDA has approved the first shock wave device indicated for patients with diabetic foot ulcers.

SANUWAVE, Inc.

Marketed as the Dermapace System, the device uses a handheld probe to deliver high-energy pulses similar to sound waves to the wound’s surface. According to the manufacturer, Sanuwave Health Inc, of Alpharetta, Georgia, the device increases perfusion and arteriogenesis, angiogenesis, biofilm disruption, and growth factor upregulation, which help regenerate skin and musculoskeletal and vascular structures.

Treatment consists of 4 to 8 brief, noninvasive applications given over 2 to 10 weeks. Monitoring and usual care are required afterward. The device is indicated for adults with diabetes who have foot ulcers lasting more than 30 days. The FDA noted that about 25% of people with diabetes will develop a foot ulcer. Poor circulation or a foot infection that doesn’t respond to treatment sometimes results in amputation.

Officials at the FDA said the agency reviewed clinical data from 2 trials that involved 336 patients with diabetes. The treatment group received usual care consisting of wet-to-dry dressings or debridement and the shock wave therapy. The control group was treated with usual care and sham shock wave therapy. Some patients’ blood glucose was well controlled while others’ blood glucose was not.

The trials’ primary end point was complete wound closure—full skin reepithelialization without the need for drainage or dressings—within 12 weeks of starting treatment. After 24 weeks, 44% of patients in the Dermapace group who received 1 to 7 treatments met the end point compared with 30% in the control group.

The most common adverse events associated with the Dermapace System were pain during treatment, local bruising and numbness, migraine headaches, nausea, syncope, wound infection, cellulitis, osteomyelitis, and fever.

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