Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications (LASER-1)

Rationale: Onychomycosis is an important problem for patients with diabetes. Nails with fungal infection become thick and distorted with resulting pressure increase and the potential for serious complications like diabetic foot ulcers. As part of the diabetic foot care program, nails of patients at risk for developing ulcers and suspected onychomycosis are frequently skived. There is no effective local therapy that cures infection; systemic antifungal medication are often withheld due to concerns for interactions with other drugs and side effects. Aim: To determine the efficacy of Nd:YAG laser therapy to treat onychomycosis in diabetes patients with risk factors for developing diabetic foot complications. Setting: A randomized, double blind, controlled trial. Study population: Patients with diabetes mellitus, with an increased risk for diabetic ulcers. Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The later procedure will be performed as a sham procedure by a second podiatrist. Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.