Controlled studies have shown that
Apligraf(R) (Organogenesis Inc., Canton, USA) is more economical and more effective at healing venous
leg ulcers (VLUs) than compression
therapy alone. However, the clinical and economic impact of
Apligraf on healing VLUs in clinical practice has not been fully examined.
METHODS: A medical chart review was conducted of patients who were treated with
Apligraf for one or more nonhealing VLUs over a 2-year period at the Henry Ford Hospital. Following
Apligraf treatment, patients were followed for up to 9 months. Primary clinical outcome measures were mean change in baseline
ulcer size (cm2) per week and percent reduction in baseline
ulcer size at final study visit. Economic evaluation of
Apligraf treatment was based on VLU-related medical care costs (US$) in relation to
ulcer size (cm2) changes before and after
Apligraf therapy.
RESULTS: Thirteen patients with 21 chronic VLUs were treated with
Apligraf. All had at least one comorbidity, most commonly
hypertension (38%). Twelve patients were known to have had a prior history of VLU. At baseline, mean
ulcer duration was 23.9 months and median
ulcer size was 13.5 cm2; for the 6 months preceding
Apligraf treatment, in which patients received conventional compression
therapy, mean
ulcer size increased +0.72 cm2 per week. During the
Apligraf post-treatment study period, mean
ulcer size decreased by -2.37 cm2 per week. At final
clinic visit,
ulcers exhibited an average 60.5% reduction in baseline size; 21
ulcers (n = 13) showed 75% or greater reduction in size, compared with baseline. Economic data were available for five patients; among these individuals
ulcer-related medical costs per unit change in
ulcer size were lower following
Apligraf treatment relative to such costs with conventional compression
therapy applied during the
Apligraf pretreatment period.
CONCLUSIONS: