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Laser Therapy for At-Home Treatment of Diabetic Foot Ulcers - Canada (LLL&DIAB-02)

Primary Purpose

Diabetic Foot Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

B-Cure Laser Pro

Sham laser

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Photobiomodulation, Low-Level Laser Therapy, over the counter

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Scarborough Health Network ; Centenary SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

B-Cure Laser Pro

Sham laser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of complete (100%) wound closure

Complete re-epithelialization without drainage

Secondary Outcome Measures

Time to complete (100%) wound closure

Time to complete re-epithelialization without drainage

Full Information

NCT ID

NCT03687580

First Posted

September 26, 2018

Last Updated

November 8, 2021

Sponsor

Scarborough Rouge Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03687580

Brief Title

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

Acronym

LLL&DIAB-02

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

October 1, 2022 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Scarborough Rouge Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

Photobiomodulation, Low-Level Laser Therapy, over the counter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

B-Cure Laser Pro

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham laser

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

B-Cure Laser Pro

Intervention Description

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

Intervention Name(s)

Sham laser

Intervention Description

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 Measure Information:

Title

Incidence of complete (100%) wound closure

Description

Complete re-epithelialization without drainage

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Time to complete (100%) wound closure

Description

Time to complete re-epithelialization without drainage

Time Frame

Up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rose Raizman, MSc, MScN

Phone

+1-416-8862328

shoshray@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rose Raizman, MSc, MScN

Organizational Affiliation

Scarborough Health Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scarborough Health Network ; Centenary Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M1E 4B9

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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