Status:
UNKNOWN
Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)
Lead Sponsor:
Erika Carmel ltd
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-90 years
Phase:
NA
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. P...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04796649
Start Date
May 15 2022
End Date
December 15 2024
Last Update
April 28 2022
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel