FDA authorizes marketing of foot ulcer treatment device

By Lyka Mae P. Chiang

The U.S. Food and Drug Administration recently authorized the marketing of the Dermapace System, the first shock wave device intended to treat foot ulcers among diabetes patients.

Dr. Binita Ashar, director of the division of surgical devices in FDA’s Center for Devices and Radiological Health, said that the agency is dedicated to extending technologies to patients with chronic diseases that will help improve their quality of life.

“Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations,” she added.

According to the Centers for Disease Control and Prevention, roughly 30.3 million people have been diagnosed with diabetes in the United States. The disease is characterized by damaged blood vessels and nerves, particularly in feet, and can lead to severe infections if left untreated. About 25 percent of diabetes patients will develop foot ulcers over time, which may lead to amputation if it fails to heal or isn’t responding well to treatment.

The Dermapace System is intended for the treatment of chronic, fully-developed diabetic foot ulcers with wound areas no larger than 16 cm2 which extend through the layers of the skin but without bone exposure. The device uses pulses of energy that is similar to sound waves to mechanically stimulate the wound. It is allowed to be used by patients 22 years and older, showing symptoms of foot ulcers lasting for more than 30 days and must be used along conventional diabetic ulcer care.

FDA authorizes marketing of foot ulcer treatment device 2

The grant of authorization followed the clinical data review made by the FDA of the two multi-center, randomized, double-blind studies which showed that patients who underwent Dermapace treatment along their usual ulcer care have seen an increase in wound healing at 24 weeks with 44 percent wound closure rate. Those treated with the sham shock wave therapy showed only a 30 percent wound closure rate during the same period of time.

Among the common side effects observed were pain during device application, local bruising and numbness, migraines, nausea, fainting, wound infection, infection in cellulitis and osteomyelitis, and fever.

March 2018 Health and Lifestyle

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