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Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

NCT01996995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-03-21

No results posted yet for this study

Summary

In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads 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 skiving 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.

Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment.

Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers.

Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser 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.

Conditions

  • Onychomycosis

Interventions

DEVICE

Nd:YAG laser pulse therapy

DEVICE

Sham procedure

Sham procedure

Sponsors & Collaborators

  • Medical Research Foundation, The Netherlands

    lead OTHER

Principal Investigators

  • H.J.G. Bilo, professor MD · Isala Diabetes Centre, Zwolle

  • Nanne Kleefstra, MD PhD · Isala Diabetes Centre,Zwolle

  • G.W.D. Landman, MD PhD · Isala Diabetes Centre, Zwolle

  • Leonie Nijenhuis - Rosien, Bsc · Isala Diabetes Centre, Zwolle

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01996995 on ClinicalTrials.gov