About 30 million people in the U.S. have diabetes, and about 25% of those will have a foot ulcer at some point. When circulation is so poor that the ulcer does not heal, or when treatment cannot stop infection, amputation may be necessary. Diabetes is the leading cause of lower limb amputations.
The FDA has approved a new treatment to help heal diabetic foot ulcers. The Dermapace System (Sanuwave, Inc., Suwanee, GA) sends shock waves to mechanically stimulate the wound. The treatment is intended for adult patients with chronic foot ulcers with wound areas no larger than 16 cm 2, extending through the epidermis, dermis, tendon, or capsule, but without bone exposure. It is used along with standard diabetic ulcer care.
In 2 multicenter studies of 336 patients, patients were given 1 to 7 treatments over 24 weeks. The shock wave systems increased wound healing by 44%. The patients treated with a sham shock wave therapy had a 30% wound closure rate.