Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: A randomised, quadruple-blind, sham controlled trial (LASER-1)

BACKGROUNDS: Patients with diabetes mellitus are at high risk for onychomycosis, which is related to development of foot ulcers.

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the treatment of onychomycosis with local laser therapy.

METHODS: In a single-centre, randomised (1:1), quadruple blind, sham-controlled trial, patients with diabetes mellitus, at risk for developing diabetic foot ulcers (Sims classification score 1,2) and a clinical suspicion on onychomycosis were randomised to either 4 sessions neodymium- doped yttrium aluminium garnet (Nd-YAG) 1064nM laser or sham treatment. The primary outcome was clinical and microbiological cure of onychomycosis after one-year follow-up.

RESULTS: From March 2015 to July 2016 64 patients were randomised; 63 could be analysed. Trichophyton rubrum was the most detected pathogen. There was no difference in the primary outcome between laser and sham treatment. With the exception of a subungual hematoma in the fifth toenail occurring 2 weeks after laser treatment, the results suggested that treatment with Nd-YAG 1064nM laser is safe.

CONCLUSION: At this moment, there is no evidence of any effect of laser treatment for onychomycosis in patients with diabetes at increased risk for foot ulcers, at least not within one year after treatment. This article is protected by copyright. All rights reserved.