Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically of living cells (fibroblasts) and/or structural proteins, to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.
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