Skin substitute heals diabetic ulcers
Novartis Pharmaceuticals in East Hanover, NJ, recently announced it has received Food and Drug Administration approval for Apligraf (Graftskin) for use with conventional diabetic foot ulcer care in the treatment of diabetic foot ulcers of greater than three weeks' duration.
In a clinical trial of more than 200 patients with diabetic foot ulcers, Apligraf was shown to heal more diabetic foot ulcers faster than conventional therapy alone. By 12 weeks of treatment, 56% of diabetic foot ulcers treated with Apligraf were 100% closed, compared with 39% of ulcers treated with conventional therapy alone.
Apligraf consists of living skin cells and structural protein. The lower dermal layer combines bovine type 1 collagen and human dermal cells, producing additional matrix proteins. The upper epidermal layer is formed by prompting human epidermal cells first to multiply and then to differentiate to replicate the architecture of human skin. Unlike human skin, Apligraf does not contain melanocytes, macrophages, lymphocytes, blood vessels, hair follicles, or sweat glands.
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