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:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03881267
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old.
* Presence of a VLU on the leg, below the knee but above the aspect of the medial malleolus, extending at least through the dermis or subcutaneous tissue but not involving tendon, muscle, or bone.
* The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
* Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit, as of the date subject consents for study.
* Index ulcer is a minimum of 2.0 cm2 and a maximum of 20 cm2 at first screening visit (SV1) and first treatment visit (TV1).
* Adequate circulation to the affected extremity as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow within 3 months of SV1, using the affected study extremity.
* The index ulcer has been treated with high compression for at least 14 days prior to randomization (30-40 mm Hg).
* Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
* Subject understands and is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
* Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures have been completed.
* The index ulcer has a clean granular base, is free of necrotic debris, and appears to be healthy vascularized tissue at time of placement of treatment product.
* Subject is deemed healthy and stable for treatment based per PI discretion.
Exclusion Criteria:
* Subjects with a BMI ≥45
* Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
* Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
* Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
* Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
* History of radiation at the ulcer site (regardless of time since last radiation treatment).
* Index ulcer has been previously treated or will need to be treated with any prohibited therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
* Study ulcer requiring negative pressure wound therapy during the course of the trial.
* Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
* Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
* Subject is pregnant or breast-feeding.
* Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization.
* Subjects with end stage renal disease as evidenced by a creatinine greater than 3.0mg/dl within 120 days of randomization.
* Target wound has presence of local active soft tissue infection involving the treatment site.
* Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
* In the opinion of the Investigator, evidence of unstable human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
* Vascular surgery; arterial or venous to the affected extremity within 30 days of screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03881267
Study Brief:
Protocol Section:
NCT03881267