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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT04484168
Eligibility Criteria:
Inclusion Criteria
Primary or recurrent venous leg ulcer
Long or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for \>0.5 seconds
Ankle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial Index(TBI) ≥ 0.5 acceptable), or a palpable pulse
Ulcer size between 1 and 200 cm2
Patient suitable for full compression bandaging
Exclusion criteria Pregnancy (or breastfeeding and needing to feed within 48 hours of treatment)
Active infection of ulcer, or infection within the last two weeks
Leg ulcer of non-venous aetiology as determined by clinical assessment
Isolated perforator vein reflux only
Evidence of deep venous insufficiency or thrombosis
Known hypersensitivity to Sotradecol or similar sclerosants
Previous inability to tolerate compression bandages
Presence of any contraindications for the use of compression bandages:
Absence of a palpable pulse, and Ankle Brachial Index (ABI) \<0.8
Decompensated congestive cardiac failure (NYHA Class IV)
Known hypersensitivity to any of the component materials
Patients unable to provide informed consent
Patients attending the leg ulcer clinic already will be excluded from enrolment with the same ulcer but will be eligible to enrol with a contralateral ulcer. Recurrent ipsilateral ulcers will not be excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04484168
Study Brief:
Protocol Section:
NCT04484168