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.