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What Does it Treat?

Apligraf is Indicated for use along with standard compression therapy in venous ulcers of at least 1 month in duration that have not adequately responded to conventional ulcer therapy.

Apligraf is also indicated for use with conventional diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which extend through the dermis but without tendon, muscle, capsule or bone exposure.

Venous Leg Ulcers

In a large-scale clinical trial, Apligraf plus compression therapy was more effective in achieving complete wound closure by week 24 than compression therapy alone (57% vs 40%, P=.022, Cox Proportional Hazards Regression Analysis). In patients with ulcers > 1 year's duration (n=120) Apligraf plus compression therapy was more than twice as effective in achieving complete wound closure by week 24 (47% vs 19%, P<.002). These data compare with 66% vs 73% (Apligraf vs control), P=.434, for patients with ulcers < 1 year's duration (n=120).

Note: In an open label prospective Phase IV study of Apligraf of 50 patients with Venous leg ulcers un responsive to conventional therapy and of greater than 1 year’s duration, 74% complete wound closure was achieved with Apligraf. Median time to heal was < 2 months. (footnote 2 from VLU sales aid

Diabetic Foot Ulcers

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 38% (36/ 96) of ulcers treated with conventional therapy (debridement plus saline dressings alone and total off-loading) [P= .0026] .*

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

In an open-label multi-center study of 50 patients with diabetic foot ulcers that were not adequately responding to conventional therapy, 70% of patients had their wounds completely closed by Apligraf within 12 weeks.(footnote: reference 1 DFU Brochure).