FDA approves new treatment for diabetic foot ulcers
The approval is an expanded indication for the device, which covers the ulcer and allows skin and tissue to regenerate and heal the wound.
The FDA in January approved an expanded indication for the Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers that last longer than 6 weeks.
The device, which is made of silicone, cow collagen, and shark cartilage, covers the ulcer and allows skin and tissue to regenerate and heal the wound. Its new indication is based on a clinical study that showed it improved ulcer healing compared to standard diabetic foot ulcer care (51% vs. 32% of patients, respectively, had healed ulcers after 16 weeks).
Adverse events included infections, increased pain, swelling, nausea, and new or worsening ulcers. The device should not be used on infected wounds or in patients with allergies to bovine collagen or chondroitin.