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Only a month and 12 days after receiving recommendation for approval from a FDA advisory board, Apligraf was formally given approval for the treatment of diabetic foot ulcers of greater than a three-week duration.
Apligraf, supplied as a bi-layered living skin substitute, received FDA marketing clearance in 1998 for use in the treatment of venous leg ulcers. In clinical trials, Apligraf was shown to heal more diabetic foot ulcers faster than conventional therapy alone. By 12 weeks of treatment, 56 percent of diabetic foot ulcers treated with Apligraf were 100 percent closed, compared to 39 percent treated with conventional therapy alone.
"Apligraf will change the way we manage our patients with diabetic foot ulcers," says Lawrence B. Harkless, DPM, professor of podiatric medicine and surgery at the University of Texas Health Sciences Center in San Antonio, Texas. "The burden of diabetic foot ulcers to individuals and society demonstrates the need for new and better products to treat these devastating wounds."
Between 600,000 to 800,000 people in the United States currently suffer from diabetic foot ulcers.
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Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.