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 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.

  • Ulcers on the lower leg or ankle area developed 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 developed due to high blood sugar levels are 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 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.


  • After 24 weeks of the trial period, patients under dermaPACE system had increased wound healing with a wound closure rate of 44 percent. Patients under sham shock wave therapy had 30 percent wound closure rate.
  • Recurrence of wounds in the participants under dermaPACE system was less than 10 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 device treatment. The common side effects observed with dermaPACE device 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.

A Device for the treatment of venous, arterial, ischemic, diabetic feet, decubitus, pressure or bed sores ulcers.

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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