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Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)

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ClinicalTrials.gov Identifier: NCT04796649
Recruitment Status : Not yet recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Erika Carmel ltd

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


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: B-Cure laser pro Device: Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Masking: Double (Participant, Investigator)
Masking Description: sham control
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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.

Active Comparator: Standard treatment + Sham laser
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.
Device: Sham
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.




Primary Outcome Measures :
  1. Incidence of complete (100%) wound closure [ Time Frame: up to 3 months ]
    Complete re-epithelialization without drainage


Secondary Outcome Measures :
  1. Time to complete (100%) wound closure [ Time Frame: up to 3 months ]
    Time to complete re-epithelialization without drainage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:18-90 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 4 weeks prior to the screening visit
  7. Ulcer grade classified as ≤ IIIA according to University of Texas Classification of Diabetic Foot Ulcers.
  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 0.7 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 - evidence of gangrene on any part of affected limb infection at time of screening, deep vein thrombosis (DVT), active malignancy, anemia (Hb<9 gr/dL)
  2. Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings
  3. Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 4 weeks of screening
  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. Has serum albumin level of<3 mg%
  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

Information from the National Library of Medicine

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): NCT04796649


Contacts
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Contact: Ilan Friedman, M.D. +972-50-7163046 friedmanilan@gmail.com
Contact: Assaf Hamawi, M.D assafyehu@gmail.com

Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Erika Carmel ltd
Investigators
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Principal Investigator: Nachum Greenberg, M.D Shaare Zedek Medical Center
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Responsible Party: Erika Carmel ltd
ClinicalTrials.gov Identifier: NCT04796649    
Other Study ID Numbers: 0550-20-SZMC
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erika Carmel ltd:
Photobiomodulation, Low-Level Laser, Wound Healing
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases