The FDA has approved the sale of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the CDC. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat.
About 25% of people with diabetes will experience a foot ulcer. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.
The Dermapace System, marketed by Sanuwave, Inc, is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2
(about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. It is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients 22 years and older, with diabetic foot ulcers lasting for more than 30 days. The Dermapace should be used along with standard diabetic ulcer care.
“Diabetes is the leading cause of lower limb amputations,” Binita Ashar, MD, director of the division of surgical devices in FDA’s Center for Devices and Radiological Health, said in a statement
. “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.”
The FDA reviewed clinical data from 2 multicenter, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.
The patients who had between 1 and 7 treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44% wound closure rate. Patients treated with the sham shock wave therapy showed a 30% wound closure rate.
The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.