The US Food and Drug Administration (FDA) recently approved the ‘Integra Omnigraft Dermal Regeneration Matrix’ device to treat diabetic foot ulcers. The device, made of silicone, cow collagen and shark cartilage, is placed over the sore and provides an environment that favors development of new skin and tissue.
The Omnigraft device was first approved in 1996 to treat life-threatening burns when a skin graft is not possible. The device is now approved for diabetic foot ulcers lasting longer than six weeks that do not involve any exposed bones, joints or tendons.
Of the 29 million people diagnosed with diabetes in the United States each year, about 25 percent are expected to develop a foot ulcer, the FDA said. Such ulcers lead to about 50,000 amputations each year.
In tests conducted by the FDA, some 51 percent of Omnigraft users had healed ulcers after 16 weeks, compared to 32 percent of participants treated with standard ulcer care alone. Adverse reactions to the device included infection, increased pain, swelling, nausea and new or worsening ulcers. The agency warned that the device should not be used by people allergic to any of its components or who have an infected wound, the agency said.