B-cure Laser for Healing Diabetic Foot Ulcers
Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Recruiting
N/A
Interventional Study
Diabetic Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 95
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Scarborough Rouge Hospital · Other
Who this trial is looking for
This trial is looking for people with diabetic foot ulcers to test how well a home-use laser device can help heal these wounds. Participation involves using the B-cure laser device along with standard treatment for your ulcer.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 18 to 95 years old.
- I have type 1 or type 2 diabetes.
- I have a diabetic foot ulcer that has lasted at least 3 months.
- My ulcer is at least 2 cm2 after cleaning.
- I can take care of my wound dressing myself.
- I agree to use effective birth control if I am female and able to become pregnant.
- I have provided signed consent to participate.
You may not be able to join if
- I have an active cancer.
- I am currently undergoing or scheduled for vascular surgery.
- I have anemia (low blood hemoglobin).
- I have had radiation or chemotherapy within the last 3 months.
- I am taking immunosuppressive medications.
- I have uncontrolled diabetes (HbA1c > 12%).
- I have a history of substance abuse in the last 6 months.
- I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 accel…
Trial Locations
Loading…
Loading trial locations…
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 M…
Contacts