Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT06754735
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years and able to provide written informed consent
* Patients who have a chronic venous leg ulcer (VLU) below the knee at or above the malleolus determined to be due to underlying venous disease
* Venous reflux ≥ 500 mil sec/superficial or 1 sec/deep or venous mapping after interventions following a vascular procedure
* VLU of ≥ 1.5cm2 and ≤ 50cm2 after debridement at study enrolment i.e. Screening visit
* \*Cluster wounds where the sum of the full thickness ulcer area must be ≤ 50cm2
* Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry
* The index ulcer has been treated with CCD of at least 30mmHg for ≥ 6 weeks prior to screening.
* Adequate perfusion with Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry AND TcpO2 \> 30mmHg OR Biphasic arterial duplex below the knee OR Toe pressure \> 30mmHg OR TBI .6
* Wound size reduction in a 2-week run-in period of ≤ 30%
* Subject understands and is willing to participate in the clinical study and comply with weekly visits and follow up regime
* Subject has read and signed IRB/EC approved ICF before screening procedures commence
Exclusion Criteria:
* • Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy
* Acute thrombophlebitis or Deep Vein Thrombosis (DVT) and within three months preceding study entry
* Subject awaiting venous ablation or is less than 30 days post ablation
* Surgery during three months prior to study entry (such as abdominal, gynecological, hip or knee replacement)
* Wound etiology of uncertain origin or history or prior diagnosis of Systemic Lupus Erythematosus, Burger's Disease, Pyoderma Gangrenosum or other inflammatory ulceration, vasculitis
* Documented evidence of osteomyelitis on any part of affected limb
* Index ulcer has exposed bone, muscle and tendon
* Index ulcer exhibits signs of unmanaged wound infection or severe clinical infection that requires hospitalization or immediate surgical intervention
* BMI \> 45
* Uncontrolled diabetes: HbA1c \> 12% within 60 days of screening
* Renal dialysis or of screening EGFR less than 30 mg/dl
* NYHA Class IV
* Peripheral arterial reconstruction/revascularization on the affected limb within the last 30 days
* Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids \> 10mg daily dose, immunosuppressive agents).
* Active systemic treatment for malignancy
* History of radiation at the ulcer site
* Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayer cell therapy, dermal substitute, extracellular matrix) within 14 days before screening
* Subject participated in another investigational device, drug or biological trial within four weeks prior to study entry
* Subject may not be pregnant or breastfeeding at the time of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06754735
Study Brief:
Protocol Section:
NCT06754735