Diabetic Foot Ulcer
Conditions
Keywords
Photobiomodulation, Low-Level Laser Therapy, over the counter
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.
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.
Interventions
DEVICEB-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
DEVICESham 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
Sponsors
Scarborough Rouge Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The active and sham devices are externally identical and emit the same guiding light. The only difference is that the sham does not emit the therapeutic near infrared rays. However, since near infrared laser light is invisible to the human eye, the treatment allocation cannot be determined.
Intervention model description
Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complete (100%) wound closure | Up to 3 months | Complete re-epithelialization without drainage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete (100%) wound closure | Up to 3 months | Time to complete re-epithelialization without drainage |
Countries
Canada
Contacts
Primary ContactRose Raizman, MSc, MScN
Outcome results
None listed