The U.S. Food and Drug Administration (FDA) has just given the green light for the marketing of a new device for treating diabetic foot ulcers. Known as the dermaPACE system, it’s the first shock-wave device for foot ulcers.
Diabetic foot ulcers are sores or wounds that occur on the feet of people with diabetes, usually on the bottom. They are caused by damage to the nerves or blood vessels, or both, when diabetes is poorly controlled. The condition occurs in about 15% of those with diabetes, and when left untreated, foot ulcers can result in reduced circulation, infection, and even amputation.
Shockwave technology has been used in medicine for some 30 years. It’s been employed in orthopedic treatments and as a way of shattering kidney stones (it’s also been used by veterinarians). Success in these procedures gave indications that the technology might be effective in the healing of wounds, which led to the development of what’s known as Pulsed Acoustic Cellular Expression, or PACE. The dermaPACE device, which was developed by Sanuwave, a technology firm based in Suwanee, Georgia, is the first to employ PACE technology for wound treatment. It works by using energy pulses to stimulate wounds and is intended for diabetes patients aged 22 and above who have experienced foot ulcers for more than 30 days.
The FDA approved the device after reviewing the results of two multicenter studies. The 336 subjects of the studies were divided into two groups — one received PACE treatments and the other received an ineffective, or sham, treatment. After receiving one to seven treatments over a 24-week period, the PACE group experienced wound closure treatments at a rate of 44%, while the sham therapy group had a 30% rate.
Technology watchers now expect that the dermaPACE breakthrough will lead to a wider use of shockwave technology in medicine.