Electric stimulation as an adjunct to heal diabetic foot ulcers: a randomized clinical trial

OBJECTIVE: To evaluate high-voltage, pulse-galvanic electric stimulation as an adjunct to healing diabetic foot ulcers. DESIGN: Randomized, double-blind, placebo-controlled pilot trial. SETTING: University medical center. PATIENTS: Forty patients with diabetic foot ulcers, consecutively sampled. Twenty patients each assigned to treatment and placebo groups. Five patients (2 treated, 3 placebo) withdrew because of severe infection. INTERVENTIONS: Electric stimulation through a microcomputer every night for 8 hours. The placebo group used identical functioning units that delivered no current. Additional wound care consisted of weekly débridements, topical hydrogel, and off-loading with removable cast walkers. Patients were followed for 12 weeks or until healing, whichever occurred first. MAIN OUTCOME MEASURES: Proportion of wounds that healed during the study period. Compliance with use of device (in hr/wk), rate of wound healing, and time until healing. RESULTS: Sixty-five percent of the patients healed in the group treated with stimulation, whereas 35% healed with placebo (p = .058). After stratification by compliance, a significant difference was identified among compliant patients in the treatment group (71% healed), noncompliant patients in the treatment group (50% healed), compliant patients in the placebo group (39% healed), and noncompliant patients in the placebo group (29% healed, linear-by-linear association = 4.32, p = .038). There was no significant difference in compliance between the 2 groups. CONCLUSION: Electric simulation enhances wound healing when used in conjunction with appropriate off-loading and local wound care.