The U.S. FDA has reportedly given a nod for the marketing and deployment of the Dermaspace system, a device used to treat foot ulcers in the diabetes patients. According to a key official of the FDA, the severity of diabetes can lead to the amputation of lower limbs in patients, which may now be prevented on account of Dermaspace. It has further been stated that the main objective of the FDA is to approve the use of those technologies that can improve the life quality in the patients suffering from chronic ailments such as diabetes.
The Centers for Disease Control and Prevention (CDC) has claimed that nearly 30.3 million residents across the U.S. have been suffering from diabetes. Diabetes apparently causes more harm to blood vessels of the feet and can result in infections, which cannot be treated with medicines. It is projected that approximately 25% of diabetics can experience a foot ulcer wound, which sometimes requires amputation if the wound does not respond to the treatment. According to the healthcare service providers and physicians, the Dermaspace equipment can be used to treat these foot ulcers, which remain uncured for over a month in adult diabetes patients.
The FDA has studied the clinical data derived from medical tests carried out on 336 diabetics using Dermaspace System shock wave treatment mode with regular care and a sham shock wave mode of treatment. It was found that the patients receiving the Dermaspace System shock wave therapy (between one to seven treatments) demonstrated a rapid rate of recovery from foot ulcers in twenty-four weeks with a 44% rate of wound closure. The patients who received Sham shock wave treatment however, exhibited a thirty percent closure rate in 24 weeks. The positive outcomes observed from the clinical experiments conducted on the diabetes patients have thus, reportedly led the U.S. drug controlling authority to approve the Dermaspace device to treat foot ulcers in diabetics.