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A Pooled Analysis

David J. Margolis, MD, MSCE; Jonathan Kantor, MA; Jill Santanna, MS; Brian L. Strom, MD, MPH; Jesse A. Berlin, ScD

Arch Dermatol. 2000;136:1531-1535.

Objective  To estimate the effect of various risk factors on the probability that neuropathic diabetic foot ulcers will heal within 20 weeks of care.

Design and Setting  A pooled or meta-analysis of individual patient data from the standard care arms of 5 randomized clinical trials was conducted. We analyzed 586 subjects with diabetes mellitus who had a neuropathic diabetic foot ulcer. All patients received good wound care, debridement, and "off-loading" of the wound.

Main Outcome Measure  Multivariable logistic regression was used to calculate the magnitude of the association of each risk factor with patients having healed wounds.

Results  Logistic regression odds ratios (ORs; 95% confidence intervals [95% CIs]) revealed that those patients with a diabetic neuropathic foot ulcer that healed within 20 weeks using standard care were more likely to have a smaller wound (OR = 0.67; 95% CI, 0.55-0.81), a wound that existed for a shorter period (OR = 0.73; 95% CI, 0.61-0.87), and be nonwhite (OR = 0.64; 95% CI, 0.43-0.96) compared with patients whose wounds did not heal within 20 weeks. The patient's age (OR = 0.99; 95% CI, 0.89-1.01), serum level of glycosylated hemoglobin at the start of the study (OR = 1.03; 95% CI, 0.97-1.10), and sex (OR = 1.02; 95% CI, 0.69-1.50) were unassociated with the probability of wound healing. Substantial heterogeneity was not found among the studies.

Conclusions  A standard care regimen for diabetic neuropathic foot ulcers is most likely to be effective for patients who have wounds that are small and of brief duration. This information should help dermatologists decide initially whether to use standard care, to try a new treatment, or to refer the patient to a specialty center.

From the Departments of Dermatology (Dr Margolis) and Biostatistics and Epidemiology (Mr Kantor, Ms Santanna, and Drs Strom and Berlin), Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia. The sponsors of the randomized, controlled clinical trials provided no funds for this analysis. None of the authors have a financial or consulting relationship with the sponsors of the pooled studies.

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