The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm 2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”Īn estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
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