FDA permits marketing of dermaPACE device to treat diabetic foot ulcers
High blood sugar or glucose levels (a condition known as type 2 diabetes T2D) damages small blood vessels and restricts blood supply through them to nerves. Nerves and nerve fibers will be damaged as blood rich with essential nutrients, glucose and oxygen could not be delivered to them. An individual affected by nerve damage will lose sensation in those areas. Nerves will become susceptible to infections and injury due to nerve damage, leading to ulcers development. Studies show high blood sugar or glucose levels is the major cause of lower limb amputations.
Suwanee, Georgia, the United States based Sanuwave Health has developed a dermaPACE device, a novel shock wave device for the treatment of acute and chronic wounds or ulcers. This device was developed using Sanuwave's proprietary and patented "Pulsed Acoustic Cellular Expression" (PACE) technology. This technology uses external high-energy acoustic shock waves (similar to sound waves) to stimulate the wound and to 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 treat ulcer areas of size not more than 16 cm2. The standard diabetic ulcer care should be used along with the dermaPACE device treatment. The device can treat wounds or ulcers such as.
Clinical trial for 24 weeks duration was conducted among 336 diabetic foot ulcer patients at 39 centers. Prior to trial, participants were under usual ulcer treatment and 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 device treatment. The common side effects observed with dermaPACE device treatment were
The CE marked dermaPACE device has got marketing permission on December 28, 2017, from the United States Food and Drug Administration.
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Published by Jammi Vasista, Chennai, India.