A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of Low-Level Laser Therapy on Venous Leg Ulcers

Abstract

This study aimed to determine the effect of low-level laser therapy (LLLT) on chronic venous leg ulcers (VLUs). A double-blinded prospective randomized controlled trial was conducted to compare incidence of complete wound closure, ulcer size and pain reduction in patients randomized to 24 treatments of placebo or LLLT (635 nm) over 12 weeks. Patients presented with a 6-week history of VLUs ranging in size from 5 to 20 cm². Venous origin was confirmed by Doppler ultrasound and an ankle brachial index of 0.8 or greater. Of 24 patients, 23% of the test group (n = 13) and 18% of placebo group (n = 11) achieved complete wound closure. At 12 weeks, patients in test and placebo groups had a mean surface area reduction of 6.26 cm² ( P < .0001) and 6.72 cm² ( P < .005), respectively, and a mean pain score decrease of 43.54 points ( P < .0001) and 25.73 points ( P = .002) respectively. Differences between groups was not statistically significant for wound closure ( P = 1.0) or ulcer size ( P = .80). Mean ulcer pain was significantly reduced from initiation of treatment compared with 4 weeks' follow-up after 12 weeks with LLLT ( P < .01). Within the limitations of the study, LLLT may not have early effects as an adjunctive therapy to wound healing of VLUs, but LLLT may have delayed effects on VLU healing and associated pain, which requires further study.

Keywords: low-level laser therapy; randomized controlled trial; venous leg ulcers; wound healing.