Laser therapy for onychomycosis in patients with diabetes at risk for foot
complications: study protocol for a randomized, double-blind, controlled trial
(LASER-1).
Author(s): Nijenhuis-Rosien L(1,)(2), Kleefstra N(3,)(4,)(5), Wolfhagen MJ(6), Groenier
KH(7,)(8), Bilo HJ(9,)(10,)(11), Landman GW(12,)(13).
Affiliation(s): Author information:
(1)Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands.
l.nijenhuis@isala.nl. (2)Innofeet Voetencentrum Nijenhuis Podiatry, Simon
Stevinweg 13, 8013 NA, Zwolle, the Netherlands. l.nijenhuis@isala.nl. (3)Diabetes
Centre, Isala, Dr Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands.
n.kleefstra@isala.nl. (4)Department of Internal Medicine, University of
Groningen, University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen,
the Netherlands. n.kleefstra@isala.nl. (5)Langerhans Medical Research Group,
Postbus 21, 4254 ZG, Sleeuwijk, the Netherlands. n.kleefstra@isala.nl.
(6)Department of Medical Microbiology, Isala, Dr. van Heesweg 2, 8025 AB, Zwolle,
the Netherlands. m.j.h.m.wolfhagen@isala.nl. (7)Diabetes Centre, Isala, Dr
Spanjaardweg 11, 8025 BT, Zwolle, the Netherlands. k.h.groenier@umcg.nl.
(8)Department of General Practice, University of Groningen, University Medical
Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.
k.h.groenier@umcg.nl. (9)Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT,
Zwolle, the Netherlands. h.j.g.bilo@isala.nl. (10)Department of Internal
Medicine, University of Groningen, University Medical Center Groningen,
Hanzeplein 1, 9700 RB, Groningen, the Netherlands. h.j.g.bilo@isala.nl.
(11)Department of General Practice, University of Groningen, University Medical
Center Groningen, Hanzeplein 1, 9700 RB, Groningen, the Netherlands.
h.j.g.bilo@isala.nl. (12)Diabetes Centre, Isala, Dr Spanjaardweg 11, 8025 BT,
Zwolle, the Netherlands. g.w.d.landman@isala.nl. (13)Department of Internal
Medicine, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, the
Netherlands. g.w.d.landman@isala.nl.
Publication date & source: 2015, Trials. , 16:108
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.
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