(RxWiki News) For the estimated 29 million US patients diagnosed with diabetes, diabetic foot ulcers are a real risk. But a new device could help.
Today, the US Food and Drug Administration (FDA) approved the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers.
“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, MD, MPH, acting director of the FDA's Office of Device Evaluation, in a press release. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”
According to Centers for Disease Control and Prevention (CDC) estimates, about a quarter of the 29 million US diabetes patients will develop foot ulcers.
"Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year," according to the FDA.
Diabetes is a chronic condition in which the body does not produce enough insulin, a hormone that regulates blood sugar. Untreated diabetes can lead to heart and kidney disease, among other health problems — including diabetic foot ulcers. That's where Omnigraft could step in.
The device — made from cow collagen, shark cartilage and silicone — is placed over the ulcer, creating an environment conducive to new skin and tissue formation. Integra, which markets the device, received FDA approval to use Omnigraft for burns back in 1996.
The FDA has now approved the device for diabetic foot ulcers based on a study that found that it was safe and effective. After 16 weeks of treatment with Omnigraft, 51 percent of treated study patients had healed ulcers. For patients treated with standard care for diabetic foot ulcers, that figure was 32 percent. Standard care includes surgical bandaging, cleaning and keeping weight off of the affected foot.
Some patients in this study reported side effects. These included new or worse ulcers, swelling, nausea, infections and increased pain. According to the FDA, patients with cow collagen or cartilage allergies should not use Omnigraft.