FDA Approves Diabetic Foot Ulcer Indication for Omnigraft

Miriam E Tucker

January 08, 2016

The US Food and Drug Administration has approved the Integra Dermal Regeneration Template (Integra LifeSciences) for the additional indication of the treatment of nonhealing diabetic foot ulcers.

The device, composed of silicone, cow collagen, and shark cartilage, is an advanced skin-replacement three-dimensional porous matrix, designed to provide immediate wound closure and permanent regeneration of the dermis. It is placed in direct contact with the excised wound and acts as a scaffold for cell migration, allowing for regeneration of the dermal layer of the patient's skin.

The new approval is for the treatment of certain diabetic foot ulcers lasting longer than 6 weeks that do not involve exposure of the joint capsule, tendon, or bone, in conjunction with standard diabetic ulcer care. It will be marketed for the new indication under the name Integra Omnigraft Dermal Regeneration Matrix.

The product was previously licensed by the FDA in 1996 for the treatment of life-threatening burn injuries when the patient's own skin isn't available for a graft and in 2002 for use in reconstructive surgery for burn scars under the same circumstances.

Approval Based on Newly Published FOUNDER Trial

The approval is based on a 16-week multicenter, randomized, controlled, parallel group clinical trial called Foot Ulcer New Dermal Replacement (FOUNDER) Study, conducted under an investigational device exemption in which Omnigraft was added to standard diabetic foot ulcer care, including cleaning and bandaging the wound and off-loading the affected foot.

Results were published in November (Wound Repair Regen. 2015;23:891-900) and showed that of 154 patients assigned to additionally receive Omnigraft vs 153 who just got standard of care, Omnigraft produced healing in 51% vs 32% (P = .001) of ulcers after 16 weeks, with a 59% improvement in the incidence of complete wound closure with Omnigraft compared with standard care.

Adverse events seen in the trial included infections, increased pain, swelling, nausea, and new or worsening ulcers.

The FOUNDER investigators conclude that "for the treatment of chronic diabetic foot ulcers, IDRT treatment [Omnigraft] decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life, and had fewer adverse events compared with the standard-of-care treatment. IDRT could greatly enhance the treatment of nonhealing diabetic foot ulcers."

The FDA notes that Omnigraft should not be used in patients with allergies to bovine collagen or chondroitin (cartilage from any source). It should also not be used on infected wounds.

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