Integra LifeSciences (NSDQ:IART) said today it won expanded FDA approval for its Omnigraft dermal regeneration matrix, now indicated to treat diabetic foot ulcers.

The device, made of silicone, cow collagen and shark cartilage, is placed over the ulcer to provide a new environment for the skin and tissue to regenerate and heal the wound, according to the Plainsboro, N.J.-based company.

“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,” FDA Center for Devices and Radiological Health device evaluation office director Dr. William Maisel said in an FDA press release.

Integra 1st won FDA approval for its Omnigraft in 1996 for treating life threatening burn injuries when the use of an individual’s own skin for a graft was not possible. The indication was expanded in 2002 for use in treating patients undergoing reconstructive surgery for burn scars, according to the press release..

The new indication allows the Omnigraft to be used to treat foot ulcers that last longer than 6 weeks and do not involve exposure of the joint capsule, tendon or bone, along with standard diabetic ulcer care, according to the FDA release.

The approval for the indication was approved based on a clinical study in which 51% of patients treated with the Omnigraft had healed ulcers after 16 weeks, comapred to 32% treated only with standard diabetic foot ulcer care.

An estimated 25% of the 29 million individuals in the U.S. with diabetes will develop foot ulcers in their life time, according to the Center for Disease Control and Prevention.