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.


METHODS
Randomized, double-blind, placebo-controlled pilot trial.


METHODS
University medical center.


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
Electric simulation enhances wound healing when used in conjunction with appropriate off-loading and local wound care.
Peters
E J
EJ
Mexican American Medical Treatment Effectiveness Research Center, Department of Orthopaedics, University of Texas Health Sciences Center, San Antonio, TX, USA.
Lavery
L A
LA
Armstrong
D G
DG
Fleischli
J G
JG
D017719:Diabetic Foot / Q000628:therapy*; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010865:Pilot Projects; D016019:Survival Analysis; D013997:Time Factors; D014945:Wound Healing