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Photobiomodulation

B-Cure Laser Pro for Foot Ulcer (LLL&DIAB-02 Trial)

N/A
Waitlist Available
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
Awards & highlights

LLL&DIAB-02 Trial Summary

This trial will test whether a home-use low-level laser device is effective for accelerating healing of diabetic foot ulcers.

Eligible Conditions
  • Diabetic Foot Ulcers

LLL&DIAB-02 Trial 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

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

LLL&DIAB-02 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to volunteer for this clinical research?

"This clinical trial is currently enrolling 60 patients aged between 18 and 95 that have ulcers. To qualify, participants must demonstrate satisfactory arterial perfusion (either ABI over 0.5 or documented confirmation), agree to comply with all procedures, possess an ulcer area of at least 2 cm2 in size after debridement, and be capable/willing to learn how to apply dressings correctly."

Answered by AI

How many individuals are taking part in this clinical experiment?

"Affirmative. According to data on clinicaltrials.gov, this medical trial posted on February 1st 2019 is actively searching for volunteers. The total requirement of participants stands at 60 and they will be recruited from one single site."

Answered by AI

Are participants still being accepted for this trial?

"Affirmative, the particulars on clinicaltrials.gov manifest that this trial is actively enlisting patients. The study was first advertised on February 1st 2019 and most recently revised on November 8th 2021. Sixty test subjects need to be recruited from a single health facility."

Answered by AI

Is the age range for this research project accommodating seniors?

"This medical trial is enrolling participants who are between 18 and 95 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Rose Raizman 2019. "Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03687580.
~10 spots leftby Apr 2025
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