At-home laser treatment for diabetic foot ulcers in Canada

Effectiveness and Safety of a Home-Use Low Level Laser Therapy Device As an Adjunct to Standard Treatment Compared to Standard Treatment Alone, for Diabetic Foot Ulcers: a Double Blind, Randomized, Sham-Controlled Clinical Study

This study is testing if using a home laser device along with regular care can help people with diabetic foot ulcers heal faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Scarborough Rouge Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT03687580 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the B-Cure laser, a home-use low-level laser device, in accelerating the healing of diabetic foot ulcers when used alongside standard treatment. Patients with diabetic foot ulcers will receive standard care and will be randomly assigned to either an active laser treatment group or a sham treatment group for self-administration at home. Wound healing will be assessed every two weeks, and any adverse events will be documented throughout the study. The hypothesis is that the addition of the B-Cure laser will enhance healing compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-95 with type 1 or type 2 diabetes who have a diabetic foot ulcer that has persisted for at least three months.

Not a fit: Patients with ulcers that do not meet the specified criteria or those with inadequate arterial perfusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with diabetic foot ulcers, reducing complications and healthcare costs.

How similar studies have performed: Other studies have shown promising results with low-level laser therapy for wound healing, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or Female
4. Age:18-95 years old at the time of Informed Consent (Adult, Senior)
5. Type 1 or type 2 Diabetes Mellitus
6. Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 3 months prior to the screening visit
7. Ulcer grade classified as ≥2 according to Wagner grading system.
8. Area of ulcer (after debridement) is at least 2 cm2
9. Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.5 or that have documented confirmation of adequate arterial perfusion
10. Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes
11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria:

1. Pre-existing conditions - active malignancy,
2. Anemia (Hb\<8 gr/dL)
3. Scheduled to undergo vascular surgery, angioplasty, or thrombolysis at the time of enrollment.
4. History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
5. Taking immunosuppressive medication
6. Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
7. HbA1c \> 12% (uncontrolled hyperglycemia)
8. A documented history of alcohol or substance abuse within 6 months of screening
9. Currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results
10. Pregnant at the time of screening
11. Has any photobiomodulation (low level laser) device at home

Where this trial is running

Toronto, Ontario

• Scarborough Health Network ; Centenary Site — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Rose Raizman, MSc, MScN — Scarborough Health Network
• Study coordinator: Rose Raizman, MSc, MScN

Conditions Diabetic Foot Ulcer; Photobiomodulation; Low-Level Laser Therapy; over the counter