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 patient s (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 debridements, topica l hydrogel, and off-loading with removable cast walkers. Patients were foll owed for 12 weeks or until healing, whichever occurred first. Main Outcome Measures: Proportion of wounds that healed during the study pe riod. Compliance with use of device tin hr/wk), rate of wound healing, and time until healing. Results: Sixty-five percent of the patients healed in the group treated wit h stimulation, whereas 35% healed with placebo (p = .058), After stratifica tion 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, linea r-by-linear association = 4.32, (v = .038). There was no significant differ ence in compliance between the 2 groups. Conclusion: Electric simulation enhances wound healing when used in conjunc tion with appropriate off-loading and local wound care. (C) 2001 by the American Congress of Rehabilitation Medicine and the Americ an Academy of Physical Medicine and Rehabilitation.