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

Primary Purpose

Diabetic Foot Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
B-Cure laser pro
Sham
Sponsored by
Erika Carmel ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Photobiomodulation, Low-Level Laser, Wound Healing

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard and B-Cure Pro

Standard treatment + Sham laser

Arm Description

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.

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.

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

First Posted
March 11, 2021
Last Updated
April 27, 2022
Sponsor
Erika Carmel ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04796649
Brief Title
Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)
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
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erika Carmel ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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, Wound Healing

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
ParticipantInvestigator
Masking Description
sham control
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard and B-Cure Pro
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment + Sham laser
Arm Type
Active Comparator
Arm Description
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.
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
Intervention Description
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 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
90 Years
Accepts Healthy Volunteers
No
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:18-90 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 4 weeks prior to the screening visit Ulcer grade classified as ≤ IIIA according to University of Texas Classification of Diabetic Foot Ulcers. 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 0.7 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 - 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) Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 4 weeks of screening 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 Has serum albumin level of<3 mg% 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
Ilan Friedman, M.D.
Phone
+972-50-7163046
Email
friedmanilan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Assaf Hamawi, M.D
Email
assafyehu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nachum Greenberg, M.D
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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

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