Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1)
نویسندگان
چکیده
BACKGROUND In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes-related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent shaving and clipping of the nails. No effective curative local therapies exist, and systemic agents are often withheld due to concerns for side effects and interactions. METHODS/DESIGN The primary aim is to evaluate the efficacy of four sessions of Nd:YAG 1064 nM laser application on the one-year clinical and microbiological cure rate in a randomized, double-blind, sham-controlled design with blinded outcome assessment. Mandatory inclusion criteria are diagnosis of diabetes, risk factors for developing foot ulcers defined as a modified Simm's classification score 1 or 2 and either neuropathy or PAD. A total of 64 patients are randomized to intervention or sham treatment performed by a podiatrist. DISCUSSION This study will be the first double-blind study that investigates the effects of local laser therapy on onychomycosis, specifically performed in patients with diabetes with additional risk factors for foot complications. TRIAL REGISTRATION Clinical trials.gov as NCT01996995 , first received 22 November 2013.
منابع مشابه
Low Level Laser Therapy in Treatment of Diabetic Foot Ulcers: Double Blind Controlled Clinical Trial
متن کامل
Effect of Low-Level Laser Therapy on Muscle Strength and Endurance and Post-Exercise Recovery of Young Adult: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Background. Recovery or post-exercise rehabilitation is an essential part of exercise training. Low-level Laser Therapy (LLLT) is a modality increasing interest for recovery because of having a conservative and non-aggressive method. LLLT also decreases the production of fatigue-related biomechanical markers, such as lactate, C-reactive protein (CRP), and Creatine kinase (CK). Objectives. To i...
متن کاملMaintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial
Background Patients with arrested preterm labor (PTL) are at increased risk for recurrence of preterm birth (PTB). Maintenance tocolysis after arrest of acute PTL is of questionable value. The objective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order to prevent PTB in women with episodes of threatened PTL. MaterialsAndMethods This is a randomized double blind ...
متن کاملAdjunctive Low-level Laser Therapy Using 980-nm Diode Laser after Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
Background and Objective: Extraction of impacted lower third molars is one of the most frequent surgeries of the oral cavity. This operation might be accompanied by inevitable complications, such as pain, swelling, and trismus after surgery. Therefore, the aim of this study was to evaluate the impact of low-intensity/power laser therapy on swelling and trismus after impacted mandibular third mo...
متن کاملAloe vera Leaf Gel in Treatment of Advanced Type 2 Diabetes Mellitus Needing Insulin Therapy: A Randomized Double-Blind Placebo-Controlled Clinical Trial
Background: Advanced type 2 diabetes mellitus (T2DM) needing insulin therapy is a common disease. Previous studies indicate that aloe (Aloe vera L.) leaf gel may positively affect the blood glucose and lipid levels in patients with advanced T2DM needing insulin. Objective: Evaluation of the efficacy and safety of aloe leaf gel in the treatment of type 2 diabetic patients resistant to ...
متن کامل