FDA Approves Treatment for Diabetic Foot Ulcers

Health Writer
Medically Reviewed

About 25 percent of people with diabetes will develop a foot ulcer at some point. Chronic foot ulcers can slowly worsen, causing tissue and bone infections, and in the worst case, end up resulting in amputation.

There is a new treatment available that helps these foot ulcers heal.

The U.S. Food and Drug Administration approved a new product to treat certain diabetic foot ulcers. The Integra Omnigraft Dermal Regeneration Matrix, or Omnigraft for short, is made of silicone, cow collagen, and shark cartilage. Omnigraft is placed over the ulcer, creating an environment in which new skin and tissue form to heal the wound.

This new approval came after a clinical study showing that Omnigraft improved ulcer healing when compared with the current standard treatment of ulcers, for example cleaning and covering the wound with a surgical bandage and keeping weight off the foot.

The study showed that 52 percent of patients whose ulcers were treated with Omnigraft healed within 16 weeks, as compared to 32 percent of those getting standard care.

There are some contraindications: Omnigraft can’t be used in patients who are allergic to cow collagen or chondroitin (a component of cartilage), and can’t be used on infected wounds.

Omnigraft is approved for use on diabetic foot ulcers that last longer than six weeks and do not involve exposure of the joint capsule, tendon, or bone. Your doctor can help you decide if Omnigraft is right for you.