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The Effectiveness of Topical Becaplermin for the Treatment of Diabetic Neuropathic Foot Ulcer
Author(s) -
Margolis D.J.,
Bartus C.,
Hoffstad O.,
Magee G.
Publication year - 2008
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2005.130215ah.x
Subject(s) - medicine , wound care , amputation , diabetic foot , propensity score matching , cohort , retrospective cohort study , logistic regression , surgery , wound healing , relative risk , diabetic foot ulcer , diabetes mellitus , confidence interval , endocrinology
The goal of this study was to specifically estimate the effectiveness of Becaplermin, which is recombinant human platelet derived growth factor (rhPDGF). This was the first FDA‐approved growth factor therapy for the treatment of diabetic neuropathic foot ulcer (DNFU). The previously published pivotal trials have shown that those who used rhPDGF were about 35%(i.e., a relative risk (RR) of about 1.35) more likely to heal by the 20 th week of care. In our study treatment effectiveness was estimated in a retrospective cohort study, controlling for treatment selection bias using propensity scores derived from logistic regression. The cohort that we studied were patients with a DNFU treated at a Curative Health Services‐affiliated wound care center between 1998–2004. We noted 25,098 individuals with a DNFU and overall about 10% received rhPDGF. We were able to successfully create a propensity score model such that the distributions of patient age and gender, wound duration, wound area, wound grade, treating center, and wound location were evenly balanced between those who received rhPDGF and those who did not. The RR for a wound to heal after treatment with rhPDGF as compared to standard care after 20 weeks of care at a wound care center was 1.33 (1.28, 1.38). With respect to amputation, the RR for having an amputation after receiving rhPDGF was 0.86 (0.77, 0.97). In conclusion, rhPDGF is more effective than standard therapy in both helping a wound to heal and preventing amputation. The effectiveness of rhPDGF with respect to getting a wound to heal is similar “in this real‐world setting” as the efficacy estimates from the previously published randomized controlled trials. Acknowledgments: Funding for this study was provided by Ethicon to the Trustees of the University of Pennsylvania.