FDA approves silicone regeneration matrix for diabetic ulcers

The Food and Drug Administration (FDA) has approved a matrix device made from silicone, cow collagen and shark cartilage to treat certain diabetic foot ulcers

The Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) is placed over diabetic ulcers and provides an environment for new skin and tissue to regenerate and heal the wound.

Chronic diabetic foot ulcers are associated with tissue and bone infections and result in 50,000 amputations each year according to the Centers for Disease Control and Prevention.

William Maisel, acting director of the office of device evaluation in the FDA’s center for devices and radiological health, said: “We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal.

“Healing of these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”

Omnigraft is approved to treat certain diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care.

Omnigraft’s new indication is based on a clinical study that demonstrated that the matrix 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. 

Omnigraft is manufactured by Integra LifeSciences Corporation of Plainsboro, New Jersey.