The FDA Has Approved a New Device to Treat Diabetic Foot Ulcers

People with diabetes often suffer from a host of foot ailments. Poor blood sugar control can result in nerve damage and circulation problems. This can result in weakness, numbness, pain, and other issues in the feet.

Lack of blood flow to the area can mean wounds heal very slowly, and patients are more prone to developing ulcers and other conditions that may be difficult to get rid of. Roughly a quarter of people with diabetes will get at least one foot ulcer in their lifetime.

Photo: Adobe Stock/Liv Friis-larsen
Photo: Adobe Stock/Liv Friis-larsen

“Diabetes is the leading cause of lower limb amputations,” says Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

Now a new device, known as DermaPACE, has been approved by the FDA to help with diabetic foot ulcers. Its technology dates back 30 years, when it was used to break up kidney stones, but researchers are just now beginning to use it to heal ulcers in patients with diabetes.

The shockwave device, produced by Sanuwave, is used externally to stimulate a wound up to the size of a soda can lid using “pulses of energy similar to soundwaves.”

Photo: Adobe Stock/Africa Studio
Photo: Adobe Stock/Africa Studio

Article continues below

Our Featured Programs

See how we’re making a difference for People, Pets, and the Planet and how you can get involved!

The device is to be used in a medical setting in conjunction with traditional ulcer treatments, and it should only be used on patients 22 years of age or older who have had an ulcer for longer than 30 days. The ulcer can be treated with the device if it affects the epidermis, dermis, tendon, or capsule, but no bone can be exposed.

In two random double-blind clinical trials, patients were treated with anywhere from one to seven DermaPACE sessions, resulting in improved wound healing at 24 weeks with an average wound closure rate of 44 percent. Patients in the control group only saw a 30 percent closure rate in that time.

Side effects of the DermaPACE device include, “pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.”

Click “next” below to learn more about diabetic neuropathy and how it can affect your feet.


Support Research

Fund Diabetes research and care at The Diabetes Site for free!