The US Food & Drug Administration (FDA) has permitted the marketing of the Dermapace System, the first shock wave device intended to treat patients with diabetic foot ulcers.
The Dermapace System is intended to be used for treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 that extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The device is an external (extracorporeal) shock wave system that uses pulses of energy to mechanically stimulate the wound. It is intended for adult patients aged 22 years and older who present with diabetic foot ulcers that have lasted for more than 30 days. The Dermapace System (Sanuwave, Inc) should be used along with standard diabetic ulcer care.
“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, MD, director of the division of surgical devices at the 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.”
The FDA reviewed clinical data from 2 multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or removal of damaged tissue as needed, plus the Dermapace System shock wave therapy or usual care plus non-working 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 had a 30% wound closure rate during the same time period.
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.
FDA permits marketing of device to treat diabetic foot ulcers [press release]. U.S. Food & Drug Administration. December 28, 2017. Accessible at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590784.htm