Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B-Cure Laser Pro, Sham laser.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Device B-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 - Device Sham 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
Primary outcome measures
- Incidence of complete (100%) wound closure [Time frame: Up to 3 months]
Secondary outcome measures (1)
- Time to complete (100%) wound closure [Time frame: Up to 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Scarborough Health Network ; Centenary Site — Toronto
Identifiers
NCT: NCT03687580 · SUR-18-010