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Laser Therapy

Laser Treatment for Fungal Nail Infection

N/A
Waitlist Available
Led By Thomas G Elliott, MBBS
Research Sponsored by BCDiabetes.Ca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare a new laser treatment for fungal toe infections against the standard antifungal medication. 60 patients will be selected, 30 for each treatment.

Eligible Conditions
  • Fungal Nail Infection
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Microbiological Cure
Side effects from laser treatment
Secondary outcome measures
Clinical cure by visual assessment
Quality of Life

Side effects data

From undefined Phase 3 trial • 518 Patients • NCT00443898
23%
Headache
14%
Nasopharyngitis
8%
Back pain
6%
Influenza like illness
6%
Upper respiratory tract infection
1%
Cardiac failure congestive
1%
Lower limb fracture
1%
Cellulitis
1%
Multiple myeloma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle 48 w
Terbinafine 24 w
Vehicle 24 w
Terbinafine 48 w

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Laser TreatmentExperimental Treatment1 Intervention
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.
Group II: Standard Treatment (control group)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

BCDiabetes.CaLead Sponsor
4 Previous Clinical Trials
798 Total Patients Enrolled
BritaMed, Inc.Industry Sponsor
Thomas G Elliott, MBBSPrincipal InvestigatorUniversity of British Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Laser Treatment for Onychomycosis in Diabetes
2018. "Laser Treatment for Onychomycosis in Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02019446.
All > Gestational Diabetes > Diabetes
~9 spots leftby Apr 2025
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