Food and Drug Administration
U.S. Department of Health and Human Services
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T00-29 Print Media: 301-827-6242
June 20, 2000
Consumer Inquiries: 888-INFO-FDA
FDA today approved used of a new type of wound dressing to help heal diabetic foot ulcers, open foot sores that lead to thousands of amputations each year in people with diabetes.
The product, called Apligraf, is intended to be used on patients who have not responded well to standard methods of treating foot ulcers.
Manufactured by Organogenesis Inc., Canton, Mass., Apligraf was previously approved by FDA to treat leg ulcers caused by circulatory problems.
Apligraf is a cellular, bi-layered skin substitute produced from bovine collagen and cells derived from human infant foreskins. Its special composition allows it to provide wound protection and foster the growth of healthy new skin.
Normally doctors treat diabetic foot ulcers by cleaning them, applying temporary wound dressings and advising patients to keep weight off the foot. But those measures have a limited effect.
The new product is not a replacement for these procedures, but is intended to be used along with them to help aid healing.
FDA based its approval of Apligraf for expanded use for diabetic foot ulcers on a review of clinical studies of safety and effectiveness conducted by Organogenesis and on the recommendation of the Plastic and Reconstructive Devices Panel of FDA’s Medical Devices Advisory Committee.
In clinical studies, 112 patients were treated with Apligraf and the standard care and 96 were treated with standard care alone. Patients received 12 weeks of treatment and three months of follow up. Some 56 percent of patients in the Apligraf group had complete wound closure 12 weeks after initial treatment. That compared to 39 percent who received standard care alone. More than 80 percent of the ulcers remained closed after four weeks for both groups.
Side effects, including wound infections, occurred at similar rates for both groups.
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