Effectiveness of Platelet Releasate for the Treatment of Diabetic Neuropathic Foot Ulcers
Abstract
OBJECTIVE—The goal of this study was to specifically estimate the effectiveness of platelet releasate, a widely available treatment administered by a proprietary group of wound care centers (WCCs) for the treatment of diabetic neuropathic foot ulceration.
RESEARCH DESIGN AND METHODS—Treatment effectiveness was estimated in a retrospective cohort study controlling for treatment selection bias using logistic regression–derived propensity scores.
RESULTS—Platelet releasate was more effective than standard care. The relative risk for a wound to heal after treatment with platelet releasate compared with standard care at a WCC varied from 1.14 (95% CI 1.03–1.27) to 1.59 (1.49–1.70). The effect was greatest in those with the most severe wounds, i.e., large wounds that affect deeper anatomical structures.
CONCLUSIONS—Within the limitations of the ability of propensity score analysis to control for selection bias, platelet releasate is more effective than standard therapy. This effect is more pronounced in more severe wounds. Unfortunately, severe wounds have not been evaluated in randomized clinical trials of new interventions. We encourage the inclusion of these patients in future trials.
- CHS, Curative Health Service
- FDA, Food and Drug Administration
- PR, platelet releasate
- WCC, wound care center
Footnotes
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Address correspondence and reprint requests to David J. Margolis, Departments of Dermatology and Biostatistics and Epidemiology, Room 815 Blockley Hall, 423 Guardian Dr., University of Pennsylvania School of Medicine, Philadelphia, PA 19104. E-mail: dmargoli{at}cceb.med.upenn.edu.
Received for publication 19 September 2000 and accepted in revised form 30 November 2000.
B.L.S. and J.A.B. have received a grant from Curative Health Services.
A table elsewhere in this issue shows Système International (SI) units and conversion factors for many substances.