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

NCT ID: NCT03687580

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2026-10-01

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

B-Cure Laser Pro

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.

Group Type: EXPERIMENTAL

B-Cure Laser Pro

Intervention Type: 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

Sham laser

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.

Group Type: SHAM_COMPARATOR

Sham laser

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scarborough Rouge Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rose Raizman

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rose Raizman, MSc, MScN

Role: PRINCIPAL_INVESTIGATOR

Scarborough Health Network

Locations

Scarborough Health Network ; Centenary Site

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rose Raizman, MSc, MScN

Role: CONTACT

shoshray@gmail.com

+1-416-8862328

Other Identifiers

SUR-18-010

Identifier Type: -

Identifier Source: org_study_id