FDA approves Integra Dermal Regeneration Template (now Omnigraft)for the treatment of diabetic foot ulcers -Integra LifeSciences.

Integra LifeSciences Holdings Corporation announced that the FDA has approved the PMA Supplement for Integra Dermal Regeneration Template (IDRT) for the treatment of diabetic foot ulcers (DFU). The approval of this new indication is based on results from the FOUNDER (FOot Ulcer New DErmal Replacement) Study, a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). the approval of IDRT for the treatment of diabetic foot ulcers.

The FDA first approved Integra Dermal Regeneration Template (which the company now also calls Omnigraft) in 1996 for the treatment of life threatening burn injuries when the use of a patient’s own skin for a graft was not possible. In 2002, Integra Dermal Regeneration Template was approved for a new indication to treat patients undergoing reconstructive surgery for burn scars when they cannot have skin grafts. Now, 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.