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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03687580
Other study ID # SUR-18-010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date October 1, 2023

Study information

Verified date November 2021
Source Scarborough Rouge Hospital
Contact Rose Raizman, MSc, MScN
Phone +1-416-8862328
Email shoshray@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients with diabetic foot ulcers will receive standard treatment and in addition will be randomly allocated to receive either active or sham laser device to self treat at home. The patient's wound will be evaluated every 2 weeks. Adverse events will be documented. The study hypothesis is that B-Cure laser treatments as an adjunct therapy to standard treatment, applied, at home, by the patient or personal care-giver, can accelerate diabetic foot ulcers healing compared to standard treatment alone.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 1, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
B-Cure Laser Pro
The B-Cure Laser Pro is a portal, non-invasive low-level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min
Sham laser
The sham laser device is externally identical to the B-Cure Laser Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays

Locations

Country Name City State
Canada Scarborough Health Network ; Centenary Site Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Scarborough Rouge Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of complete (100%) wound closure Complete re-epithelialization without drainage Up to 3 months
Secondary Time to complete (100%) wound closure Time to complete re-epithelialization without drainage Up to 3 months
See also
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