Clinical and economic impact of Apligraf for the treatment of nonhealing venous leg ulcers.
BACKGROUND
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
In a clinical practice setting, Apligraf is more effective and more economical at healing VLUs than conventional therapy alone.
Fivenson
David
D
Henry Ford Health System, Detroit, MI 48202, USA. DFivens1@hfhs.org
Scherschun
Lubomira
L
D000368:Aged; D003094:Collagen / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000453:epidemiology* / Q000209:etiology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008499:Medical Records; D008824:Michigan / Q000453:epidemiology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D017768:Skin, Artificial; D016896:Treatment Outcome
C117898:Apligraf; D003094:Collagen