The US Food and Drug Administration (FDA) has granted approval to Sanuwave for the marketing of the Dermapace System designed to treat diabetic foot ulcers.
The external shock wave device is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring less than 16cm² that extends through to the epidermis, dermis, tendon, or capsule, without bone exposure.
The device uses pulses of energy, which is similar to sound waves, to mechanically stimulate the wound.
Patients who are 22 years and older and with diabetic foot ulcers lasting for more than 30 days can use Dermapace System with standard diabetic ulcer care.
FDA Center for Devices and Radiological Health surgical devices division director Binita Ashar said: “Diabetes is the leading cause of lower limb amputations.
“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.”
Before approving the device, FDA reviewed clinical data from two multi-centre, randomised, double-blind studies that saw a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy.
Both the groups included patients with poorly and well-controlled blood glucose levels.
The patients treated with one and seven doses of the Dermapace System demonstrated an increase in wound healing at 24 weeks with a 44% wound closure rate, while those treated with the sham shock wave therapy showed a 30% wound closure rate during the same time period.