title: Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1).
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical trials.gov as NCT01996995 , first received 22 November 2013.
authors: Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. l.nijenhuis@isala.nl.|Innofeet Voetencentrum Nijenhuis Podiatry, Simon Stevinweg 13, 8013 NA, Zwolle, the Netherlands. l.nijenhuis@isala.nl.
authors: Leonie
authors: L
authors: Nijenhuis-Rosien
authors: Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. n.kleefstra@isala.nl.|Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands. n.kleefstra@isala.nl.|Langerhans Medical Research Group, Postbus 21, 4254 ZG, Sleeuwijk, the Netherlands. n.kleefstra@isala.nl.
authors: Nanne
authors: N
authors: Kleefstra
authors: Department of Medical Microbiology, Isala, Dr. van Heesweg 2, 8025 AB, Zwolle, the Netherlands. m.j.h.m.wolfhagen@isala.nl.
authors: Maurice J
authors: MJ
authors: Wolfhagen
authors: Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. k.h.groenier@umcg.nl.|Department of General Practice, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands. k.h.groenier@umcg.nl.
authors: Klaas H
authors: KH
authors: Groenier
authors: Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. h.j.g.bilo@isala.nl.|Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands. h.j.g.bilo@isala.nl.|Department of General Practice, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands. h.j.g.bilo@isala.nl.
authors: Henk J G
authors: HJ
authors: Bilo
authors: Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. g.w.d.landman@isala.nl.|Department of Internal Medicine, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, the Netherlands. g.w.d.landman@isala.nl.
authors: Gijs W D
authors: GW
authors: Landman
mesh_terms: D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000150:complications* / Q000175:diagnosis; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000175:diagnosis; D017719:Diabetic Foot / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005533:Foot Dermatoses / Q000175:diagnosis / Q000382:microbiology / Q000601:surgery*; D006801:Humans; D053685:Laser Therapy / Q000009:adverse effects / Q000295:instrumentation; D053844:Lasers, Solid-State; D009426:Netherlands; D014009:Onychomycosis / Q000175:diagnosis / Q000382:microbiology / Q000601:surgery*; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome