Laser Treatment for Onychomycosis in Diabetes

NCT02019446 | Unknown FDA Device

• 1 other identifier: H13-03369
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

type 2 diabetes mellitus; onychomycosis; laser treatment; antifungal

Outcome Measures

Primary Outcomes (2)

• Microbiological Cure

  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).

  6 months

• Side effects from laser treatment

  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

  6 months

Secondary Outcomes (2)

• Clinical cure by visual assessment

  6 months

• Quality of Life

  6 months

Study Arms (2)

Laser Treatment

EXPERIMENTAL

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

Standard Treatment (control group)

ACTIVE COMPARATOR

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

Interventions

Laser Treatment YAG laser DEVICE

YAG Laser / FOX Laser

Also known as: 1064 nm Nd:YAG laser, FOX laser

Laser Treatment

Standard Treatment (control group) terbinafine hydrochloride tablets DRUG

Terbinafine hydrochloride tablets tablets

Also known as: terbinafine hydrochloride tablets

Standard Treatment (control group)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BCDiabetes.Ca: lead
• BritaMed, Inc.: collaborator

Study Sites (1)

Diamond Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (4)

• Ledon JA, Savas J, Franca K, Chacon A, Nouri K. Laser and light therapy for onychomycosis: a systematic review. Lasers Med Sci. 2014 Mar;29(2):823-9. doi: 10.1007/s10103-012-1232-y. Epub 2012 Nov 20.

  PMID: 23179307 BACKGROUND

• Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.

  PMID: 21250792 BACKGROUND

• Zhang RN, Wang DK, Zhuo FL, Duan XH, Zhang XY, Zhao JY. Long-pulse Nd:YAG 1064-nm laser treatment for onychomycosis. Chin Med J (Engl). 2012 Sep;125(18):3288-91.

  PMID: 22964325 BACKGROUND

• Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.

  PMID: 22453588 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Onychomycosis

Interventions

Control Groups; Terbinafine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Thomas G Elliott, MBBS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas G Elliott, MBBS

CONTACT

(604) 875-5900; info@bcdiabetes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 24, 2013
• Study Start: July 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

CA (1)