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Laser Therapy
Laser Treatment for Onychomycosis in Diabetes
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
All Individual Drugs Already Approved
No Placebo-Only Group
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
- Diabetes
- Fungal Nail Infection
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Microbiological Cure
Side effects from laser treatment
Secondary study objectives
Clinical cure by visual assessment
Quality of Life
Side effects data
From undefined Phase 3 trial • 518 Patients • NCT0044389823%
Headache
14%
Nasopharyngitis
8%
Back pain
6%
Upper respiratory tract infection
6%
Influenza like illness
1%
Cellulitis
1%
Cardiac failure congestive
1%
Lower limb fracture
1%
Multiple myeloma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle 48 w
Terbinafine 24 w
Vehicle 24 w
Terbinafine 48 w
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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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