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 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT04249661
Eligibility Criteria:
Inclusion Criteria:
1. All patients age 18+ with lower limb venous ulcers as diagnosed on clinical history and examination.
2. Are willing and capable to voluntarily sign a statement of informed consent to take part in this study.
3. With an ABPI of \>/= 0.8 and/or palpable pedal pulses on clinical exam.
4. Without evidence (either clinical or diagnostic) of other causes of lower limb ulceration, namely vasculitis, local dermopathology, congenital syndromes or arterial insufficiency (see above).
5. If equipoise or disagreement between two independent clinicians exist, The ultimate decision as to inclusion/exclusion will be made by the P.I
Exclusion Criteria:
1. Patients unable to provide informed consent.
2. Patients under the age of 18
3. Patients with arterial insufficiency manifesting as ABPI's of \<0.8
4. Known or suspected alternate likely primary cause of lower limb ulceration (vasculitis, dermatological disease, underlying congenital syndrome).
5. Patients who are deemed unsuitable due to any circumstances as deemed appropriate by the P.I.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04249661
Study Brief:
Protocol Section:
NCT04249661