← Back to Search

Photobiomodulation

Laser Therapy for Foot Ulcers (LLL&DIAB-02 Trial)

N/A
Recruiting
Led By Rose Raizman, MSc, MScN
Research Sponsored by Scarborough Rouge Hospital
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 up to 3 months

Summary

This trial tests if using the B-cure laser at home can help patients with diabetic foot ulcers heal faster. The laser light is believed to make cells repair and grow quicker, aiding in wound healing. Patients will use the device along with their standard treatment. The laser has been shown to accelerate healing of acute or chronic wounds, and specifically diabetic foot ulcers.

Who is the study for?
This trial is for adults aged 18-95 with Type 1 or Type 2 diabetes and a diabetic foot ulcer that's lasted at least 3 months. They must have good blood flow in their legs and be able to change dressings. Women who can have children must use effective birth control. People with severe anemia, uncontrolled diabetes, recent cancer treatments, or those using immunosuppressants cannot join.
What is being tested?
The study tests the B-Cure Laser Pro device against a sham laser to see if it speeds up healing of diabetic foot ulcers when used at home along with standard care. Participants will randomly receive either the real or sham treatment.
What are the potential side effects?
Since this trial involves low-level laser therapy which is generally considered safe, side effects are expected to be minimal but may include mild skin irritation at the site of application.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of complete (100%) wound closure
Secondary study objectives
Time to complete (100%) wound closure

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: B-Cure Laser ProExperimental Treatment1 Intervention
Subjects from the B-Cure Laser Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device.
Group II: Sham laserPlacebo Group1 Intervention
Subjects from the Sham laser group will receive standard care and in addition will self-treat at home daily with the sham B-Cure device.

Find a Location

Who is running the clinical trial?

Scarborough Rouge HospitalLead Sponsor
3 Previous Clinical Trials
448 Total Patients Enrolled
Rose Raizman, MSc, MScNPrincipal InvestigatorScarborough Health Network

Media Library

B-Cure Laser Pro (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT03687580 — N/A
Foot Ulcer Research Study Groups: B-Cure Laser Pro, Sham laser
Foot Ulcer Clinical Trial 2023: B-Cure Laser Pro Highlights & Side Effects. Trial Name: NCT03687580 — N/A
B-Cure Laser Pro (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03687580 — N/A
~7 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top