NCT03687580 Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
| NCT ID | NCT03687580 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scarborough Rouge Hospital |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-02-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2019-02-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low level laser) is used for acceleration of wound healing. The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment.
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
Contact & Investigator
Rose Raizman, MSc, MScN
PRINCIPAL INVESTIGATOR
Scarborough Health Network
Frequently Asked Questions
Who can join the NCT03687580 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03687580 currently recruiting?
Yes, NCT03687580 is actively recruiting participants. Contact the research team at shoshray@gmail.com for enrollment information.
Where is the NCT03687580 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT03687580 clinical trial?
NCT03687580 is sponsored by Scarborough Rouge Hospital. The principal investigator is Rose Raizman, MSc, MScN at Scarborough Health Network. The trial plans to enroll 60 participants.