Laser Treatment for Onychomycosis in Diabetes

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BCDiabetes.Ca
• Collaborator: BritaMed, Inc.
• Treatments: Terbinafine

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.