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
SexALL
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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.