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Laser Treatment for Onychomycosis in Diabetes

NCT02019446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-20

No results posted yet for this study

Summary

Fungal infections of the toe affect one in three people with diabetes. Current treatments for fungal toe infections include oral medications, but these drugs often interact with other common medications. We are studying a new treatment for fungal toe infections involving the use of a laser device. We will compare to the standard treatment which is a type of antifungal medication. This laser has been tested in small numbers of patients with minimal side effects. There will be 60 participants selected for our study, of which 30 will receive standard treatment and the rest will receive laser treatment.

Conditions

  • Diabetes Mellitus, Type 2
  • Onychomycosis

Interventions

DEVICE

Laser Treatment YAG laser

YAG Laser / FOX Laser

DRUG

Standard Treatment (control group) terbinafine hydrochloride tablets

Terbinafine hydrochloride tablets tablets

Sponsors & Collaborators

  • BritaMed, Inc.

    collaborator INDUSTRY

  • BCDiabetes.Ca

    lead NETWORK

Principal Investigators

  • Thomas G Elliott, MBBS · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2020-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • Canada

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 NCT02019446 on ClinicalTrials.gov