The FDA has permitted marketing of the Dermapace System, the first shock-wave device intended to treat diabetic foot ulcers, the agency announced on Dec. 28, 2017.
The device is intended to be used with standard diabetic ulcer care in patients ages 22 years and older presenting with ulcers lasting for more than 30 days. The system uses pulses of energy to mechanically stimulate chronic, full-thickness diabetic foot ulcers with wound areas measuring no more than 16 cm2, or about the size of a soda can top. Treatable wounds may extend through the epidermis, dermis, tendon, or capsule, but without bone exposure.
In two randomized, double-blind studies of a total of 336 patients receiving usual wound care (including wet-to-dry dressings or debridement as needed) plus either the shock-wave therapy or sham therapy, patients who had between one and seven treatments with the system had an increase in wound healing at 24 weeks, with a 44% wound-closure rate. Those who received the sham treatment had a 30% wound-closure rate during the same time period.
The most common side effects of the shock-wave system were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, cellulitis, osteomyelitis, and fever.