The US FDA has recently approved first ever shock-wave device to treat foot ulcers in diabetic patients. The device harbors an extracorporeal shock wave system to mechanically stimulate the diabetic ulcers through energy pulses. Target patient and wound characteristic: Initially, the system has been approved for patient aged 22 years or older and intended for the diabetic foot ulcer with the following characteristic: Chronic presence (30days or more) Full thickness Wound size less than 16cm 2 The wound extends through the layers of epidermis, dermis, tendon, capsule The ulcer does not involve bone exposure Moreover, the device should be used as an adjunct therapy along with standard treatment for the diabetic foot ulcer.
Evidence from clinical trials: The FDA approval followed two multicenter, clinical, double-blind trials with more than 336 diabetic patients with foot ulcers. The…
