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FDA approves Omnigraft for diabetic foot ulcers
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The FDA recently expanded the indication for the Integra Omnigraft Dermal Regeneration Matrix for the treatment of certain diabetic foot ulcers, according to a company press release.
The device is used by placing it over the ulcer to provide an environment for new skin and tissue to regenerate and help heal the wound.
“We are excited to see a new innovation in diabetes care with the potential to improve the number of foot ulcers that heal,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release. “Healing these painful and debilitating ulcers is essential for patients to resume walking and other daily activities.”
The new indication is based on a clinical study where 51% of patients had healed ulcers after 16 weeks with the treatment compared with 32% of patients who were treated with standard diabetic foot ulcer care alone. Adverse events included infections, increased pain, swelling, nausea and new or worsening ulcers.
Patients should not use Omnigraft if they had allergies to cow collagen or chondroitin. It should also not be used on infected wounds.