Taiwanese researchers say that a technology that uses sound waves to stimulate healing in diabetic foot ulcers is almost three times more effective than conventional hyperbaric oxygen therapy (HBOT). The technology, called dermaPACE®, is manufactured by SANUWAVE Health Inc., a medical device company located in Alpharetta, Ga.
If the study results can be duplicated, the new therapy would be a significant new tool for the treatment of diabetic foot ulcers. The malady is one of the leading causes of the estimated 80,000 foot, toe, and leg amputations that U.S. hospitals conduct each year. Loss of sensation in nerves that have been deadened by diabetic inflammation often leads to severe undetected foot injuries that are slow to heal and prone to infection.
The randomized study, conducted at Chang Gung Memorial Hospital in Kaohsiung, Taiwan, tracked 77 patients who had chronic, non-healing diabetic foot ulcers of at least three months duration. The wounds, mostly grade III and IV on the Wagner Ulcer Classification Scale, often were infected, had pus, bone inflammation, and even gangrene. The patients were considered at risk for eventual surgery, including possible amputation.
Thirty-nine patients, with 44 diabetic foot ulcers among them, were treated with dermaPACE, while the remaining 38 patients, with 40 diabetic foot ulcers among them, received conventional HBOT therapy. The dermaPACE group received two 20-minute procedures weekly over a three-week period (two hours total). The HBOT group received five 90-minute treatments weekly for eight weeks (60 hours total). Aside from their different therapies, patients received exactly the same standard wound care treatment after each session.
The study included a second course of treatment for patients whose ulcers did not improve under either therapy during the first session.
Results from the study showed a distinct difference in results between the two therapies:
Overall, 57 percent of the diabetic foot ulcers in the dermaPACE group completely healed, versus 25 percent in the HBOT group.
After one course of treatment, dermaPACE completely healed 24 ulcers, compared with 10 ulcers using HBOT.
After a second course of treatment, dermaPACE completely healed a combined 31 ulcers, compared with 11 ulcers for HBOT.
Sixty percent of ulcers treated with HBOT remained unchanged in size and depth, compared with 11 percent of ulcers treated with dermaPACE. Eight ulcers-47 percent-in the HBOT group showed no clinical improvement after a second course of treatment, while only one ulcer (seven percent) remained unchanged in the dermaPACE group.
Researchers noted a great difference in the time and sessions required for the two therapies: dermaPACE required only 15 percent as many sessions as HBOT and only three percent as much time.
How the Two Therapies Work
The difference between the two therapies is large. In HBOT, therapists subject a wound to high levels of oxygen under pressure. Many bacteria cannot metabolize when oxygen levels are high. That inability slows or blocks their reproduction, lessening infection and giving wounds a chance to heal. But the treatment, while it can slow deterioration in a diabetic foot ulcer, in many instances does not lead to total healing.
The process used by the dermaPACE device is “Paced Acoustic Cellular Expression,” where high-energy sound waves are directed at the ulcer. The waves, which reach the wound like a shock wave, create stresses that actually stimulate the growth of new blood vessels and an inflammatory response that induces healing. Diabetic foot ulcers are so-called chronic conditions, in which the body has ceased responding urgently to the wound. By inducing an inflammatory response, dermaPACE turns the condition into an acute one where the body starts a robust healing process.
One outcome of that accelerated bodily response is increased perfusion, a term that means increased blood flow, which is crucial to the healing of a chronic wound. In the Taiwan study, perfusion increased 27 percent in the dermaPACE group after treatment, while perfusion remained statistically unchanged in the HBOT group.
The abstract of the study is available online at the Diabetes Research and Clinical Practice website.