Your session is about to expire
← 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a device at home that uses low-level laser therapy.You have received certain therapies to help with tissue growth within the past two weeks before screening.You currently have another type of cancer that is still growing or spreading.You have a record of excessive drinking or drug use in the past 6 months.You have either type 1 or type 2 diabetes.You have a foot sore caused by diabetes that has lasted for at least 3 months before the screening visit.
Research Study Groups:
This trial has the following groups:- Group 1: B-Cure Laser Pro
- Group 2: Sham laser
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.