Clinical trial NCT03687580: Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Photobiomodulation
Low-Level Laser Therapy
over the counter
Lead sponsor: Scarborough Rouge Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Incidence of complete (100%) wound closure
timeFrame: Up to 3 months
Secondary outcomes:
measure: Time to complete (100%) wound closure
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Scarborough Health Network ; Centenary Site
state: Ontario
Study officials:
affiliation: Scarborough Health Network
name: Rose Raizman, MSc, MScN
role: PRINCIPAL_INVESTIGATOR
References: