Diabetic foot ulcers are common if the severity of the conditions increases in the diabetics. Thus a first shock wave device was found which was intended to cure these ulcers. The shock wave device named Dermapace System was approved for marketing by the U.S. Food and Drug Administration to Sanuwave, Inc.
"Diabetes is the leading cause of lower limb amputations," said Binita Ashar, 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."
According to the Centers for Disease Control and Prevention, an estimated 30.3 million were diagnosed with diabetes in the U.S. Diabetes damages blood vessels and nerves (feet) and can lead to severe infections that are difficult to treat. About 25% of people with diabetes will experience a foot ulcer in their lifetime. 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 is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2. It is an external shock wave system that uses pulses of energy to mechanically stimulate the wound. The device is intended for adult patients (age ≥ 22 years), presenting with diabetic foot ulcers lasting for >30 days, and should be used along with standard diabetic ulcer care.
The FDA reviewed clinical data from two multi-center, 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 one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44% wound closure rate. Those patients treated with the sham shock wave therapy showed a 30% wound closure rate during the same time period. While the side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound and fever.
The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA's 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.