Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-01)
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|ClinicalTrials.gov Identifier: NCT03687320|
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : February 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Device: B-Cure Pro Device: Sham||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Sham control|
|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|
|Actual Study Start Date :||December 2, 2019|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Standard and B-Cure Pro
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
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 Comparator: Standard and Sham
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.
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.
- Incidence of complete (100%) wound closure [ Time Frame: up to 3 months ]Complete re-epithelialization without drainage
- Time to complete (100%) wound closure [ Time Frame: up to 3 months ]Time to complete re-epithelialization without drainage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687320
|Contact: Itay Avnifirstname.lastname@example.org|
|Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University||Recruiting|
|Tel Aviv, Israel|
|Contact: Oleg Dolkart, PhD 972-52-4262544 email@example.com|
|Principal Investigator:||Elchanan Luger, MD||Department of Orthopedic Surgery, Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University|