The worldwide diabetes epidemic shows no signs of slowing. Treating diabetic foot ulcers (DFUs), a related medical issue for approximately 6% of older adults with diabetes, costs billions of dollars each year. DFU’s lead to amputation in one in 12 cases. Two years ago, in January 2016, we first wrote about DermaPace in early 2016, before clinical trials. DermaPace treats diabetic foot ulcers with external shock waves.
The FDA recently approved SanuWave‘s to market DermaPace based on the results of the trials. According to the FDA approval release, the government agency reviewed reports and data from two double-blind studies including 336 diabetic patients. In both studies, test and control groups received DermaPace shock treatments or non-working, sham shock wave treatments in addition to conventional DFU treatments, which included wet-to-dry dressings and debridement. The group that received the sham treatments showed a 30% wound closure rate at 24 weeks. The Dermapace test group’s wound closure rate at the same 24-week point was 44%.
In consideration of the common side effects of the DermaPace treatments as well as the would healing improvement, the FDA permitted Sanuwave to market DermaPace. The FDA used a fast-track “de novo” premarket review process with DermaPace, a review pathway for new products with no legally marketed predicate devices. As a result of this approval, other products that demonstrate that they work like DerrmaPace now will be able to cite DermaPace as a predicate device in support of their approval.