Apligraf® Living Skin

It is estimated that chronic wounds like venous leg ulcers affects an estimated 600,000 to 1 million people in the United States.

Apligraf is a medical device, for the treatment of venous leg ulcers and diabetic foot ulcers. Like human skin, it consists of living cells and structural proteins.

Apligraf is intended for use with standard compression therapy for the treatment of non-infected skin ulcers due to venous insufficiency that have lasted more than 1 month and have not improved after treatment with conventional ulcer therapy. It is also intended for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than 3 weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, and capsule or bone exposure.

Apligraf works by being placed on the wound. It is then covered with a nonadhesive bandage and the area is then wrapped with an elastic compression bandage. The lower dermal layer combines bovine type 1 collagen and human fibroblasts (dermal cells), which produce additional matrix proteins. The upper epidermal layer is formed by promoting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf does not contain melanocytes, Langerhans’ cells, macrophages, and lymphocytes, or other structures such as blood vessels, hair follicles or sweat glands.

Apligraf is a unique example of new materials that - when sufficiently developed - will have the potential of improving human life for many people, who have been troubled with for instance ulcers that will not heal.