| Article 316 Published on March 30, 2018 |
FDA Permits Marketing Of dermaPACE Device For The Treatment Of Diabetic Foot Ulcers
High blood sugar (glucose) levels (type 2 diabetes. T2D) will damage the small blood vessels and restricts the supply of blood 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 a nerve damage will lose the sensation in the damaged areas. Nerves will become susceptible to infections and injury due to the nerve damage, leading to the development of ulcers. Earlier studies show that high blood sugar (glucose) levels are the major cause of the lower limb amputations.
Sanuwave Health, Suwanee, Georgia, the United States, has developed a dermaPACE device, a novel shock wave device for the treatment of an acute and chronic wound or ulcer. The "Pulsed Acoustic Cellular Expression" (PACE) technology, a proprietary and patented technology of Sanuwave, was used in the development of this device. This technology uses the external high-energy acoustic shock waves (similar to sound waves) to stimulate the wound (or ulcer) and restore the normal healing process of the body such as a repair of the tissue and regeneration and growth of the blood vessels.
This technology was being used for the past 30 years in the medical treatments and procedures. The device was designed for the treatment of chronic, full-thickness diabetic foot ulcers, but not extending to the bone level, lasting for more than 30 days. The device can be used for the treatment of an 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.
- Ulcers on the lower leg or ankle area due to vein disease. These ulcers are known as venous ulcers.
- Ulcers on fingers or toes or on the lateral surface of the ankle. These ulcers are known as arterial ulcers (also known as ischemic ulcers or wounds).
- Ulcers on foot are developed due to the high blood sugar levels, known as diabetic foot ulcers.
- Ulcers on skin areas close to the bones such as hips, heels, elbows, back and ankles. These ulcers are known as a decubitus ulcer (also known as the pressure or bed sores).
- Deep partial thickness burns.
- Post-traumatic wounds.
- Post-operative wound healing defects.
Clinical trial for 24 weeks was done on 336 patients with diabetic foot ulcer at 39 centers. Prior to the trial, participants were under the diabetic foot ulcer treatment as per the guidelines. They were either with well-controlled or poorly controlled blood sugar (glucose) levels. Patients were subjected to either with sham dermaPACE treatment plus usual care for the wound treatment or active dermaPACE plus usual care for the wound treatment. The trial shows.
- After 24 weeks of the trial period, patients undergoing the dermaPACE system had an increased wound healing with a wound closure rate of 44 percent. Patients undergoing the sham shock wave therapy had 30 percent of wound closure rate.
- Recurrence of the wounds in the participants under the dermaPACE was less than ten percent.
- When compared with the sham shock wave therapy, there was a significant reduction in the wound area in participants under the dermaPACE system.
There are minimal risks associated with the dermaPACE. The common side effects observed with the dermaPACE treatment are.
- A pain during the application of the dermaPACE system.
- Wound infection, infection in the bone (osteomyelitis) and infection in the inner layers of the skin (cellulitis).
- A migraine headache.
- Urge to vomit.
The dermaPACE, CE marked, has received the marketing approval on December 28, 2017, from the United States Food and Drug Administration.
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