People with diabetes often experience diabetic neuropathy accompanied by diabetic foot ulcers that don’t heal. With the approval of a new device from the U.S. Food and Drug Administration (FDA), people with non-healing diabetic foot ulcers have new hope.
The device, called the Integra Omnigraft Dermal Regeneration Matrix, was developed by Integra LifeSciences. It is made of silicone, cow collagen, and shark cartilage, and placed over the ulcer, which provides an environment for new skin and tissue to regenerate and heal the wound.
The FDA approved Omnigraft following a 16-week clinical trial. The trial demonstrated that the device improved ulcer healing compared to standard diabetic foot ulcer care, which includes cleaning and covering the wound with a surgical bandage and keeping weight off of the foot with the ulcer.
In the study, 51% of patients treated with Omnigraft had healed ulcers after 16 weeks compared to 32% of patients treated with standard diabetic foot ulcer care alone.
“We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities,” he added.
“The new indication for Omnigraft, supported by clinical evidence, will benefit clinicians and their patients,” said Principle Investigator Dr. Lawrence A. Lavery, DPM, MPH of University of Texas Southwestern Medical Center.
Omnigraft should not be used by patients with infected wounds or those allergic to cow collagen or chondroitin. Adverse reactions in the study included infections, nausea and swelling.
An estimated 29 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Nearly 25% of them will experience a foot ulcer during their lifetime. Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year.
Peter Arduini, Integra’s President and Chief Executive Officer, added, “This approval allows us to provide clinicians and their patients with a product backed by a robust clinical trial to treat the nearly 1 million non-healing DFUs that will occur this year.”