FDA permits marketing of dermaPACE device for the treatment of diabetic foot ulcers
High blood sugar (or glucose) levels (called type 2 diabetes. T2D) damage small blood vessels and restricts blood supply to nerves. Nerves and nerve fibers will be damaged as the blood rich with essential nutrients, glucose and oxygen could not be delivered to them. An affected individual with nerve damage will lose sensation in those areas. Nerves will become susceptible to infections and injury due to the nerve damage, leading to the development of ulcers. Studies show high blood sugar (or glucose) levels is the major cause of lower limb amputations.
Sanuwave Health, Suwanee, Georgia, the United States, has developed a dermaPACE device, a novel shock wave device for the treatment of acute and chronic wounds or ulcers. "Pulsed Acoustic Cellular Expression" (PACE) technology, a proprietary and patented technology of Sanuwave, was used in the development of this device. This technology uses external high-energy acoustic shock waves (similar to sound waves) to stimulate the wound (or ulcer) and restore normal healing process of the body such as tissue repair and regeneration and growth of blood vessels.
This technology was being used for the past 30 years in medical treatments and procedures. The device was designed for the treatment of chronic, full-thickness diabetic foot ulcers, but not extending to bone level, lasting for more than 30 days. The device can be used for the treatment of ulcer with a size not more than 16cm2. The diabetic foot ulcer treatment as per the guidelines should be followed with the dermaPACE. The device can be used for the treatment of the following.
Clinical trial for 24 weeks was conducted on 336 patients of diabetic foot ulcer at 39 centers. Prior to trial, participants were under the diabetic foot ulcer treatment as per the guidelines. They were either with well-controlled or poorly controlled blood sugar or glucose levels. Patients were subjected to either with sham dermaPACE treatment plus usual care for wound treatment or active dermaPACE plus usual care for wound treatment. The trial results show.
There are minimal risks associated with dermaPACE. The common side effects observed with dermaPACE treatment were.
The dermaPACE, CE marked, has received marketing approval on December 28, 2017, from the United States Food and Drug Administration.
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Published by Jammi Vasista, Chennai, India.