Food and Drug Administration (FDA) permitted the marketing of the Dermapace System, which is first shock wave device for the treatment of diabetic foot ulcers.
Binita Ashar, M.D., director of the division of surgical devices in Center for Devices and Radiological Health of FDA said that “Diabetes is the leading cause of lower limb amputations.” “The FDA is working to develop technologies that can help in improvement of the quality of life for people suffering chronic diseases. Additional options for successfully healing and treating ulcer wounds may help in preventing the lower limb amputations.”
According to Centers for Disease Control and Prevention (CDC), an estimated 30.3 million people in the US are suffering from diabetes Diabetes causes damage to the blood vessels and nerves in feet which lead to severe infections. About 25 percent of people with the diabetes experiences foot ulcer. When circulation is poor that the foot ulcer fails to heal or when treatment fails to stop the spread of an infection amputation is necessary
The Dermapace System is used in the treatment of chronic, full-thickness diabetic foot u lcers with wound areas measuring no longer than 16 cm2 (about the size of a can of soda can top) which extend through the dermis, epidermis, capsule, or tendon, but without bone exposure. The Dermapace System is an external (extracorporeal) shockwave system that uses pulses of energy, similar to sound waves. The device is used for adult patients (22 years or older), suffering from diabetic foot ulcers which last for more than 30 days, and should be used along with standard diabetic ulcer control.