Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS)
Venous Ulcer
About this trial
This is an interventional treatment trial for Venous Ulcer
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.
Sites / Locations
- Roscommon Unversity HospiralRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Terminal Interruption of the Reflux Source (TIRS
Axial Ablation
These patients will have foam sclerotherapy of the veins in the immediate vicinity of their venous ulcer and thereafter be managed in compression bandaging and followed up fro 6 months or until the ulcer has healed
These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux