Earlier this month the US Food and Drug Association announced the approval of a new treatment for diabetic foot ulcers. The product, Integra® Dermal Regeneration Template, is made by Integra LifeSciences Holding Company, which completed a multicenter, randomized, controlled, parallel group clinical trial, the primary endpoint of which was the incidence of complete wound closure at 16 weeks. Results from that study were published in the November/December issue of Wound Repair and Regeneration. The trial concluded that patients treated with IDRT demonstrated a 51% improvement in the incidence of complete wound closure compared to standard of care.
Diabetes currently affects an estimated 30 million people in the United States. Of those diagnosed, as many as 15% may experience a diabetic foot ulcer (DFU) in their lifetime. DFUs are both painful and debilitating, and impair mobility and other aspects of the patient’s daily life. The newly approved device, constructed of cow collagen, silicone, and shark cartilage, is placed over the ulcer, creating an environment for skin and tissue regeneration and healing of the wound. The company expects to bring the product to market by mid-year under the name Integra® Omnigraft™ Dermal Regeneration Matrix.
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Read more about the newly approved treatment here.
A press release describing the product, and announcing the FDA action may be read here.