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Surrogate End Points for the Treatment of Diabetic Neuropathic Foot Ulcers

¹ Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
² Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
³ Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania

OBJECTIVE—The goal of this study was to determine whether surrogate markers based primarily on changes in the size of a wound can be used to correctly predict which individuals with diabetic neuropathic foot ulcers will heal after 12 or 20 weeks of care.

RESEARCH DESIGN AND METHODS—This is a retrospective cohort study using the Curative Health Services database. As many as 39,918 neuropathic wounds on 20,213 individuals with diabetes were evaluated. Seven surrogates based on changes in wound size were evaluated.

RESULTS—Surrogates measured after 2, 4, or 8 weeks of care and based on percentage change in area, log healing rate, and log area ratio discriminated well with respect to differentiating between those wounds that healed and those that did not heal by the 12th or 20th week of care. For example, after 4 weeks of care, the percentage change in area can be used to correctly discriminate 76% of the time between those that healed and those that did not by the 20th week of care.

CONCLUSIONS—The surrogate markers can be used in clinical trials such that shorter and smaller trials can be conducted with reasonable accuracy in order to determine which potential new therapeutics should be studied in larger, longer trials. In addition, the surrogates may also benefit clinicians when they are trying to decide whether a wound care therapy will ultimately be successful.

Abbreviations: CHS, Curative Health Services • ROC, receiver-operating characteristic

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				D. J. Margolis The Swings and Roundabouts of Randomized Controlled Studies in Wound Healing International Journal of Lower Extremity Wounds, March 1, 2004; 3(1): 4 - 6. [PDF]