Diabetes, Heart and Cardiovascular Diseases News Chronicle.  Diabetes, Cardiovascular and Heart Diseases
 Article 316
    Published on March 30, 2018

 

FDA permits marketing of dermaPACE device for the treatment of diabetic foot ulcers

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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.



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Device for the treatment of venous, arterial, ischemic, diabetic feet, decubitus, pressure (bed) sores and ulcers.

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.


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  • 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 usually develop due to high blood sugar levels, known as diabetic foot ulcers.
  • Ulcers on skin areas close to bones such as hips, heels, elbows, back and ankles. These ulcers are known as decubitus ulcers (also known as pressure or bed sores).
  • Deep partial thickness burns.
  • Post-traumatic wounds.
  • Post-operative wound healing defects.

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.



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  • After 24 weeks of the trial period, patients undergoing dermaPACE system had increased wound healing with a wound closure rate of 44 percent. Patients undergoing sham shock wave therapy had 30 percent of wound closure rate.
  • Recurrence of wounds in the participants under the dermaPACE was less than ten percent.
  • When compared with sham shock wave therapy, there was a significant rate of reduction in the wound area in participants under a dermaPACE system.

There are minimal risks associated with dermaPACE. The common side effects observed with dermaPACE treatment were.

  • 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.
  • Fainting.

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The dermaPACE, CE marked, has received marketing approval on December 28, 2017, from the United States Food and Drug Administration.




       
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