Axial Ablation Versus Terminal Interruption of the Reflux Source (NCT04484168) | Clinical Trial Compass
UnknownNot Applicable
Axial Ablation Versus Terminal Interruption of the Reflux Source
Ireland308 participantsStarted 2020-07-21
Plain-language summary
This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.