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Laser Treatment for Onychomycosis in Diabetes

This study is not yet open for participant recruitment.
Verified February 2017 by BCDiabetes.Ca
Sponsor:
ClinicalTrials.gov Identifier:
NCT02019446
First Posted: December 24, 2013
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
BritaMed, Inc.
Information provided by (Responsible Party):
BCDiabetes.Ca
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Onychomycosis Device: Laser Treatment YAG laser Drug: Standard Treatment (control group) terbinafine hydrochloride tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Laser Treatment for Onychomycosis of the Hallux in Patients With Diabetes: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by BCDiabetes.Ca:

Primary Outcome Measures:
  • Microbiological Cure [ Time Frame: 6 months ]
    One primary outcome will be the proportion of participants with microbiological cure (by KOH and culture) by 6 months post-randomization (i.e.: initiation of treatment).

  • Side effects from laser treatment [ Time Frame: 6 months ]

    Other primary outcomes include safety outcomes. Specifically, safety outcomes of interest will include the side effects listed below:

    • Usual side effect:

      o Feeling of warmth, heat, or tingling at the laser target site (only during treatment)

    • Rare side effects:

      • Discoloration/burn marks on surface of the nail
      • Slight or mild pain (only during treatment)
      • Redness of the treated skin around the nail (lasting 24-72 hours)
    • Rare laser effect:

      o Sometimes the laser creates 'sparks' on the surface of the nail - this does not cause any problems

    • Extremely rare laser effects:

      • Blistering of the treated skin around the nail
      • Scarring of the treated skin around the nail


Secondary Outcome Measures:
  • Clinical cure by visual assessment [ Time Frame: 6 months ]
    Secondary outcomes will include the proportion of participants experiencing clinical cure by visual assessment (planimetry and photograph) will be evaluated.

  • Quality of Life [ Time Frame: 6 months ]
    The other secondary outcome will be improvement in quality of life as measured by the validated "NailQoL" questionnaire which assesses symptom, emotion, and functional domains.38


Estimated Enrollment: 60
Anticipated Study Start Date: July 2018
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Treatment
Participants randomized to laser group will undergo laser treatment at baseline and be asked to return for 2 subsequent visits six weeks apart (at weeks 6 and 12) to undergo further laser treatment of the hallux. Each visit will last approximately 45 minutes. Laser energy (1064 nm Nd:YAG) will be delivered via an optical fibre (300 μm core/320 μm clad) secured in a hand piece. Laser energy will be delivered by maintaining the tip of the optical fibre 3 mm from the treatment area to achieve around 1-1.5 mm diameter spot size (25.5 J/cm2 fluence per pulse; 10-pulse pulse-train to each spot in 0.5 seconds). Multiple treatment spots will be delivered to cover the entire area of involvement.
Device: Laser Treatment YAG laser
YAG Laser / FOX Laser
Other Names:
  • 1064 nm Nd:YAG laser
  • FOX laser
Active Comparator: Standard Treatment (control group)
Control group volunteers will be asked to dedicate the same amount of time to the project with the same number of visits. However, they will receive conventional terbinafine therapy instead of laser treatments. Therefore, each of the 3 treatment visits would last only about 20 minutes.
Drug: Standard Treatment (control group) terbinafine hydrochloride tablets
Terbinafine hydrochloride tablets tablets
Other Name: terbinafine hydrochloride tablets

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides full informed consent to participate in the study;
  • At least 19 years of age;
  • Established diagnosis of diabetes mellitus at the time of screening for the study according to Canadian Diabetes Association (CDA) criteria;
  • Clinically assessed to have subungual onychomycosis (fungal infection of the nail) of the hallux, confirmed by KOH and culture performed at the screening visit.

Exclusion Criteria:

  • Presence of necrotizing fasciitis, cellulitis, wet gangrene, gas gangrene, erythema gangrenosum, or psoriasis;
  • Presence of peripheral arterial disease defined as an ankle-brachial index less than 0.6 on either lower extremity;
  • Presence of peripheral neuropathy defined as a biothesiometry score of less than 20 volts on either lower extremity;
  • Treatment with oral terbinafine (Lamisil), itraconazole (Sporanox), or griseofulvin within 12 months of the proposed study start date;
  • Treatment with any topical antifungal medications including ciclopirox, itraconazole, or other over-the-counter remedies for toenail infection within 1 month of randomization;
  • Female of childbearing potential who does not agree to practice sexual abstinence or use a medically acceptable method of contraception for the duration of the study and for at least 1 month (30 days) after the last day of test article administration; (A woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or those women whose sexual partners are either considered sterile or using contraceptives.)
  • Has a physical disability or psychiatric diagnosis which would limit the ability to adhere to the study regimen, as judged by the Investigator;
  • Is a prisoner, or is in pre-trial;
  • Is known to be without a fixed address;
  • Has documented evidence of a history (e.g. liver testing) of substance abuse within the 12 months prior to screening for study entry;
  • Is a Workers Compensation Board (WCB) patient;
  • Is unable to easily communicate in oral and written English.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019446


Contacts
Contact: Thomas G Elliott, MBBS (604) 875-5900 info@bcdiabetes.ca

Locations
Canada, British Columbia
Diamond Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Thomas G Elliott, MBBS    (604) 875-5900    info@bcdiabetes.ca   
Principal Investigator: Thomas G Elliott, MBBS         
Sponsors and Collaborators
BCDiabetes.Ca
BritaMed, Inc.
Investigators
Principal Investigator: Thomas G Elliott, MBBS University of British Columbia
  More Information

Publications:
Responsible Party: BCDiabetes.Ca
ClinicalTrials.gov Identifier: NCT02019446     History of Changes
Other Study ID Numbers: H13-03369
First Submitted: December 16, 2013
First Posted: December 24, 2013
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no initial plan to share IPD at the moment

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by BCDiabetes.Ca:
type 2 diabetes mellitus
onychomycosis
laser treatment
antifungal

Additional relevant MeSH terms:
Nail Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Onychomycosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Terbinafine
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action