- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687580
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada (LLL&DIAB-02)
November 8, 2021 updated by: Rose Raizman, Scarborough Rouge Hospital
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rose Raizman, MSc, MScN
- Phone Number: +1-416-8862328
- Email: shoshray@gmail.com
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M1E 4B9
- Recruiting
- Scarborough Health Network ; Centenary Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female
- Age:18-95 years old at the time of Informed Consent (Adult, Senior)
- Type 1 or type 2 Diabetes Mellitus
- 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
- Ulcer grade classified as ≥2 according to Wagner grading system.
- Area of ulcer (after debridement) is at least 2 cm2
- 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
- Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes
- 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:
- Pre-existing conditions - active malignancy,
- Anemia (Hb<8 gr/dL)
- Scheduled to undergo vascular surgery, angioplasty, or thrombolysis at the time of enrollment.
- History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
- Taking immunosuppressive medication
- Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
- HbA1c > 12% (uncontrolled hyperglycemia)
- A documented history of alcohol or substance abuse within 6 months of screening
- 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
- Pregnant at the time of screening
- Has any photobiomodulation (low level laser) device at home
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B-Cure Laser Pro
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.
|
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 Comparator: Sham laser
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of complete (100%) wound closure
Time Frame: Up to 3 months
|
Complete re-epithelialization without drainage
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete (100%) wound closure
Time Frame: Up to 3 months
|
Time to complete re-epithelialization without drainage
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rose Raizman, MSc, MScN, Scarborough Health Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
September 26, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (Actual)
September 27, 2018
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 8, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUR-18-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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