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Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687320
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
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 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: Triple (Participant, Care Provider, 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
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

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 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.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 3 months prior to the screening visit
  7. Ulcer grade classified as ≤3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers.
  8. Area of ulcer (after debridement) is at least 4 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, active Charcot's foot on the study limb; infection at time of screening, deep vein thrombosis (DVT), active malignancy, being on dialysis, 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 10 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. Used oral, or IV antibiotic/antimicrobial agents or medications within 7 days of baseline
  8. Has serum albumin level of<3 mg%
  9. Presence of ulcers due to other causes not related to diabetes
  10. HbA1c > 12% (uncontrolled hyperglycemia)
  11. A documented history of alcohol or substance abuse within 6 months of screening
  12. 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
  13. Pregnant at the time of screening
  14. 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): NCT03687320


Contacts
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Contact: Itay Avni +972-52-6045211 itayavni@gd-energies.com

Locations
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Israel
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    olegd@tlvmc.gov.il   
Sponsors and Collaborators
Erika Carmel ltd
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Elchanan Luger, MD Department of Orthopedic Surgery, Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University
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Responsible Party: Erika Carmel ltd
ClinicalTrials.gov Identifier: NCT03687320    
Other Study ID Numbers: TLV-0538-18
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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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 Light Therapy
Low-Level Laser Therapy
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