A Comparative Analysis of the Cost Effectiveness of Five Advanced Skin Substitutes in the Treatment of Foot Ulcers in Patients with Diabetes

Abstract

of that consists of Abstract Objective: The purpose of this economic analysis was to generate the cost-effectiveness of five (5) advanced skin substitutes/ Cell/Tissue based Products (CTPs) in the treatment of foot ulcers in patients with diabetes (DFUs): ActiGraft® (RedDress, Pardes Hanna, Israel); Apligraf® (Organogenesis, Canton, MA); Dermagraft® (Organogenesis, Cant-on, MA) ; Grafix Core® (Smith & Nephew, Andover, MA) and EpiFix® (MiMedx, Marietta, GA). Methods: For each skin substitute product, three data points were central to the analysis: Number of applications over a 12-week course of treatment; complete healing efficacy over a 12-week course of treatment; product cost per application; the number of applications and complete healing efficacy were obtained from seven established published clinical studies. Inclusion/Exclusion criteria included either a randomized controlled trial, prospective cohort, or retrospective cohort design that included at least two study arms; reported wound healing at 12 or 16 weeks, reported number of application of products used to achieve healing and a minimum 40 subjects in the primary treatment arm. Due to the complexities of cost-benefit analysis and difficulties encountered when comparing research (i.e. different run-in periods, numbers of subjects and variable endpoints) the study selection for Apligraf, Dermagraft, Grafix and Epifix used inclusion/exclusion criteria from Samsell et al. For Actigraft, study selection was limited to a pilot study. to the four (4) other advanced products analyzed. However, the ActiGraft data sourced from a pilot study presents limitations for comparison with studies meeting Samsell’s criteria. It is the authors’ intention to update this analysis when future published studies meet this benchmark.