Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: B-Cure Pro
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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:18-90 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 ≤3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers. Area of ulcer (after debridement) is at least 4 cm2 Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.7 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 - evidence of gangrene on any part of affected limb, active Charcot's foot on the study limb; infection at time of screening, deep vein thrombosis (DVT), active malignancy, being on dialysis, anemia (Hb<9 gr/dL) Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 10 weeks of screening 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 Used oral, or IV antibiotic/antimicrobial agents or medications within 7 days of baseline Has serum albumin level of<3 mg% Presence of ulcers due to other causes not related to diabetes 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard and B-Cure Pro<br>Subjects from the Standard and B-Cure Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device. | Device: B-Cure Pro<br>* 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.<br>|
| Sham Comparator: Standard and Sham<br>Subjects from the Standard and sham group will receive standard care and in addition will self-treat at home daily with the sham B-Cure device. | Device: Sham<br>* The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete (100%) wound closure | Complete re-epithelialization without drainage | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete (100%) wound closure | Time to complete re-epithelialization without drainage | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photobiomodulation, Low-Level Light Therapy, Low-Level Laser Therapy