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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    60
  • sponsor
    Scarborough Rouge Hospital
Updated on 19 November 2021
diabetes
debridement
type 2 diabetes mellitus
healing ulcer
foot ulcer

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.

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.

Details
Condition diabetic foot ulcer, Diabetic Foot, Diabetic Foot Ulcers
Treatment Sham laser, B-Cure Laser Pro
Clinical Study IdentifierNCT03687580
SponsorScarborough Rouge Hospital
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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