Significantly more effective than conventional therapy
Incidence (%) of Complete Wound Closure Over Time (N=208)*
By 12 weeks of treatment, 56% (63/112) of diabetic foot ulcers treated with Apligraf plus conventional therapy (debridement, saline dressings, total off-loading) were 100% closed, compared to 39% (36/96) of ulcers treated with conventional therapy alone (P=.0026).
Apligraf is indicated for use with standard therapeutic compression for the treatment of noninfected partial-and full-thickness skin ulcers due to venous insufficiency of duration greater than 1 month that 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 3 weeks duration that have not adequately responded to conventional ulcer therapy and that extend through the dermis but without tendon, muscle, capsule, or bone exposure.
*Estimated frequency of complete diabetic foot ulcer wound closure as a function of time by Kaplan-Meier analysis. Download complete prescribing information.
Proven to Promote Rapid Closure of Diabetic Foot Ulcers
Median Time to 100% Wound Closure
The median time to 100% wound closure was 65 days for diabetic foot ulcers treated with Apligraf plus conventional therapy vs 90 days for ulcers treated with conventional therapy alone (P=.0026).
92% of ulcers remain closed with Apligraf
At 6 months after the initiation of therapy, the incidence of ulcer recurrence was 8% (5/63) in the Apligraf group and 17% (6/36) in the control group. (These results are not statistically different) Download complete prescribing information.
Apligraf – Lower Incidence of Osteomyelitis and Frequency of Amputation
Patients receiving Apligraf had a statistically significant (P<.05) lower incidence of osteomyelitis at the study ulcer site (2.7% vs 10.4%) compared to patients treated with conventional therapy at 6 months. (These data compare with 8.9% and 3.1%, respectively, at sites other than the study ulcer).
- All patients were screened at baseline and underwent x-ray evaluation for clinical signs of infection
- Osteomyelitis may be associated with a higher frequency of amputation in patients with diabetic foot ulcers1
Apligraf-treated patients required significantly fewer amputations/resections of the study limb (6.3% vs 15.6%) [P<.05] compared to patients treated with conventional therapy at 6 months.
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.