Actively Recruiting
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Led by Scarborough Rouge Hospital · Updated on 2024-10-22
60
Participants Needed
1
Research Sites
399 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female
- Age between 18 and 95 years at consent
- Diagnosis of type 1 or type 2 diabetes mellitus
- Diabetic foot ulcer at or below the ankle lasting at least 3 months
- Ulcer grade 2 or higher by Wagner grading system
- Ulcer area after debridement of at least 2 cm2
- Adequate arterial blood flow shown by ankle/brachial index above 0.5 or equivalent confirmation
- Patient or caregiver able and willing to perform dressing changes
- For females able to bear children: use of highly effective contraception for at least 1 month before screening and during participation
You will not qualify if you...
- Active cancer or malignancy
- Anemia with hemoglobin less than 8 g/dL
- Scheduled for vascular surgery, angioplasty, or thrombolysis at enrollment
- History of cancer in the study limb or recent radiation or chemotherapy within 3 months
- Taking immunosuppressive drugs
- Received growth factor therapy within 2 weeks before screening
- Uncontrolled high blood sugar with HbA1c over 12%
- History of alcohol or substance abuse within 6 months
- Participation in another investigational trial within 30 days that could affect results
- Pregnant at screening
- Already have a photobiomodulation (low-level laser) device at home
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scarborough Health Network ; Centenary Site
Toronto, Ontario, Canada, M1E 4B9
Actively Recruiting
Research Team
R
Rose Raizman, MSc, MScN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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