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

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Photobiomodulation, Low-Level Light Therapy, Low-Level Laser Therapy Read More

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