Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— LLL&DIAB-01  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687320
• Other study ID #: TLV-0538-18
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2021
• Source: Erika Carmel ltd
• Contact: Itay Avni
• Phone: +972-52-6045211
• Email: itayavni[@]gd-energies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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
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.

Locations

Country	Name	City	State
Israel	Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Erika Carmel ltd	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete (100%) wound closure	Complete re-epithelialization without drainage	up to 3 months
Secondary	Time to complete (100%) wound closure	Time to complete re-epithelialization without drainage	up to 3 months