Graft Device Now Approved for Diabetic Foot Ulcers

Patients with certain diabetic foot ulcers now have a new treatment option.

Integra LifeSciences’s Omnigraft Dermal Regeneration Matrix recently received FDA approval to treat diabetic foot ulcers that last longer than 6 weeks and do not involve exposure of the joint capsule, tendon, or bone.

The device should be placed over the ulcer, where it can encourage new skin and tissue to regrow and heal the wound. It should be used in conjunction with standard diabetic ulcer care.

The FDA’s nod for this new indication was based on trials that showed Omnigraft improved ulcer healing compared with standard care, which would include cleaning and covering the wound, as well as keeping weight off the foot.

In clinical trials, 51% of patients who used the Omnigraft device saw healed ulcers after 16 weeks, compared with 32% of patients who received standard care solely.

Adverse events included infections, increased pain, swelling, nausea, and new or worsening ulcers, according to the FDA.

The device was already approved for treating life-threatening burns when a skin graft is not possible, as well as for treating patients undergoing reconstructive surgery for burn scars.

Omnigraft is made of silicone, cow collagen, and shark cartilage.

“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 Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a press release. “Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”

Omnigraft should not be used in patients who have allergies to cow collagen or chondroitin, or in those who have infected wounds.