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FAQ

What Is Apligraf?

Apligraf, is supplied as living bilayered, cell based product*. It is manufactured from living cells and is available only through a physician.

What is Apligraf for?

Apligraf, a medical device, is approved for the treatment of venous leg ulcers and diabetic foot ulcers. Venous leg ulcers are a type of chronic wound that affects an estimated 600,000 to 1 million people in the United States. Apligraf is indicated for use with standard compression therapy for the treatment of noninfected skin ulcers due to venous insufficiency that have lasted more than 1 month and have not improved after treatment with 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 3 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.

What are the Key Benefits of Apligraf?

Venous Leg Ulcer

In a study of all patients with venous ulcers of greater than 1 month in duration (n=240), more patients achieved complete wound closure by 24 weeks with Apligraf plus compression therapy (57%) than with compression therapy alone (40%).† In the same study in a subset of patients with ulcers lasting for more than 1 year (n=120), Apligraf achieved complete wound healing in 47% of patients. In comparison, only 19% of compression therapy patients achieved complete wound healing. In patients with ulcers < 1 year duration Apligraf plus compression therapy closed 66% of ulcers vs. 73% for compression therapy alone. (P=.434, N=120).

Diabetic Foot Ulcer

In a large-scale clinical trial Apligraf was shown to heal more diabetic foot ulcers faster than conventional therapy alone. By 12 weeks of treatment, 56% (63/ 112) of diabetic foot ulcers treated with Apligraf were 100% closed, compared to 39% (36/ 96) of ulcers treated with conventional therapy (debridement plus saline dressings alone and total off-loading) [P= .0026].‡

In this study, Apligraf not only increased the frequency of wound closure but also decreased the time to wound closure. There was a significant difference in the median time to 100% wound closure. The median time to wound closure was 65 days for diabetic foot ulcers treated with Apligraf vs 90 days for ulcers treated with conventional therapy (debridement plus saline dressings alone and total off-loading) (P=.0026).

How Is Apligraf Unique?

Like human skin, Apligraf has 2 primary layers, a dermis and an epidermis. The epidermal layer is composed of human keratinocyte cells that form an outer protective layer. The dermal layer lies beneath the epidermis and is made up of human fibroblast cells. While matrix proteins and cytokines found in human skin are present in Apligraf, Apligraf does not contain Langerhans' cells, melanocytes, macrophages, lymphocytes, white blood cells, blood vessels, hair follicles, or sweat glands.

How Is Apligraf Applied to a Venous Leg Ulcer?

Apligraf is applied by a physician. It is placed on the wound. It is then covered with a nonadhesive bandage (to keep Apligraf in place) and the area is then wrapped with an elastic compression bandage.

How is Apligraf Applied to a Diabetic Foot Ulcer?

Ulcers should be checked for their severity and undergo debridement, a method of cutting infected or dead tissue from the wound. Afterwards, a patient should follow good wound care practices that will help the ulcer heal. Apligraf would be an "add on" to current good wound care practices.

Who Applies Apligraf?

A physician prescribes Apligraf. Apligraf is used by podiatrists, vascular surgeons, dermatologic surgeons, general surgeons, plastic surgeons and others who treat wounds.

What Happens After Apligraf is Applied?

Apligraf covers and protects the wound. It contains a combination of cytokines and growth factors found in human skin. Like human skin, Apligraf consists of living skin cells and structural proteins. 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.

When Should Apligraf Not be Used

Apligraf should not be used on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. Please consult the complete prescribing information for a complete description of Apligraf and its components.

Please see complete prescribing information for components of the shipping medium.

Who Makes Apligraf?

Apligraf was developed and is manufactured and distributed in the United States by Organogenesis Inc.

Please see complete prescribing information.

*The persistence of Apligraf cells on the wound and the safety of this device in venous ulcer patients beyond 1 year and in diabetic foot ulcer patients beyond 6 months has not been evaluated.

†Cox Proportional Hazards Regression Analysis used to adjust for pooled data, and factors known to impact wound healing, which include baseline ulcer area and ulcer duration (57% vs 40%, adjusted, P=.022; 55% vs 49%, unadjusted, P=.365).

‡Estimated frequency of complete wound closure by Kaplan-Meier analysis.

References:
1. Ramsey SD, Newton K, Blough D, et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999; 22:382-387.

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