The Food and Drug Administration has approved the first shock wave device for use on individuals with diabetic foot ulcers. Sanuwave Health’s Dermapace System uses a handheld probe to deliver high-energy pulses to the wound’s surface.
Treatment includes four to eight brief, noninvasive applications over a period of two to 10 weeks. It is recommended for adults with diabetes who have had foot ulcers for more than 30 days. About 25% of people with diabetes will develop a foot ulcer. Combined with poor circulation or an infection, this often can lead to amputation.
The FDA reviewed two clinical trials that followed 336 patients aiming for complete wound closure — with no need for drainage or dressings — within 12 weeks. After 24 weeks, 44% of patients in the Dermapace group who received up to seven treatments met that goal, compared to 30% in a control group.
The treatment group received usual care with wet-to-dry dressings or debridement and shock wave therapy. The control group was treated with usual care and sham shock wave sessions.
From the April 01, 2018 Issue of McKnight's Long-Term Care News
