Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: a randomized, quadruple‐blind, sham‐controlled trial (LASER‐1)

Abstract

Background Patients with diabetes mellitus are at high risk for onychomycosis, which is related to the 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, randomized (1:1), quadruple‐blind, sham‐controlled trial, patients and microbiological confirmation with diabetes mellitus, at risk for developing diabetic foot ulcers (Sims classification score 1, 2) and a clinical suspicion on onychomycosis, were randomized to either four sessions neodymium‐doped yttrium aluminium garnet (Nd‐YAG) 1064 nm laser or sham treatment. The primary outcome was clinical and microbiological cure of onychomycosis after 1‐year follow‐up. Results From March 2015 to July 2016, 64 patients were randomized; 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 haematoma in the fifth toenail occurring 2 weeks after laser treatment, the results suggested that treatment with Nd‐YAG 1064 nm 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 1 year after treatment.

Combination of a triple wavelength (650 nm, 810 nm, and 915 nm) class IV laser system and local mechanical abrasion in the treatment of chronic toenail onychomycosis: an uncontrolled prospective pilot study

“…Some of the hypotheses already published are the heat fungicidal action over fungi, keratin proteins denaturation, the possible laser influence on cellular oxidative reactions, and changes in host immune modulation. [11][12][13][14] The results of this and other studies 9,10 suggest that laser therapy is not effective in treating onychomycosis. Until now laser treatments have not kept their promises in onychomycosis treatment, and well-designed successful clinical trials are still missing.…”

“…The fewer positive fungal cultures could be easily explained as an effect of the mechanical abrasion effectively decreasing fungal load from the nail, leaving less material for positive fungal culture. 8 Also other treatment studies of laser did not show effects on fungal cure: A randomized, quadruple-blind, sham-controlled trial from Nijenhuis-Rosien et al 9 with 63 patients showed no significant differences in a complete and microbiological cure rate of onychomycosis between four treatment sessions (baseline and after 2, 4, and 12 weeks) with Nd-YAG laser (wavelength 1,064 nm, fluency 20 J/cm 2 , spot size 3 mm, pulse rate of 5 Hz, power 10 W, and pulse duration 132 ms) and sham procedure in patients with diabetes. Before starting with (laser or sham) treatment, all affected nails were ground.…”

Race reporting and representation in onychomycosis clinical trials: A systematic review

“…Of the 302 PubMed initial search results, 182 clinical trials (28,352 participants) met inclusion criteria and were included in the final analysis 6–186 . The PRISMA study selection process is detailed in Figure 1.…”

Combination Therapy Should Be Reserved as Second-Line Treatment of Onychomycosis: A Systematic Review of Onychomycosis Clinical Trials

“…However, trials were relatively short, with an average follow-up of 32.5 weeks (SD: 14.3; range: 13.04–62.0 weeks). RCTs on photodynamic and laser monotherapies had a similar average follow-up of 35.3 weeks (SD: 11.5; range: 24.0–52.0 weeks) [ 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 ], which suggests that procedural studies, in general, lack the long-term follow-up that is sufficient to determine efficacy of onychomycosis treatment. Furthermore, in our review, some monotherapy and combination arms did not demonstrate efficacy for severe onychomycosis cases [ 35 ].…”