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

NCT03687580 | Recruiting DMC

• 1 other identifier: SUR-18-010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Photobiomodulation; Low-Level Laser Therapy; over the counter

Outcome Measures

Primary Outcomes (1)

• Incidence of complete (100%) wound closure

  Complete re-epithelialization without drainage

  Up to 3 months

Secondary Outcomes (1)

• Time to complete (100%) wound closure

  Up to 3 months

Study Arms (2)

B-Cure Laser Pro

EXPERIMENTAL

Subjects from the B-Cure Laser Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device.

Device: B-Cure Laser Pro

Sham laser

SHAM COMPARATOR

Subjects from the Sham laser group will receive standard care and in addition will self-treat at home daily with the sham B-Cure device.

Device: Sham laser

Interventions

B-Cure Laser Pro DEVICE

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

B-Cure Laser Pro

Sham laser DEVICE

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

Sham laser

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scarborough Rouge Hospital: lead

Study Sites (1)

Scarborough Health Network ; Centenary Site

Toronto, Ontario, M1E 4B9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Rose Raizman, MSc, MScN

  Scarborough Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rose Raizman, MSc, MScN

CONTACT

+1-416-8862328; shoshray@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: February 1, 2019
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)