Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
Trial Parameters
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 a