Axial Ablation Versus Terminal Interruption of the Reflux Source

Study Overview
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Brief Summary
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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.

Official Title
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Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial

Conditions
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Venous Ulcer

Intervention / Treatment
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* Procedure: Terminal Interruption of the Reflux Source
* Procedure: Axial Ablation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terminal Interruption of the Reflux Source (TIRS<br>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 | Procedure: Terminal Interruption of the Reflux Source<br>* Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer<br>|
| Active Comparator: Axial Ablation<br>These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux | Procedure: Axial Ablation<br>* Endovenous ablation of venous reflux in the main superficial veins of the leg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing | The main outcome measure is the proportion of ulcers which have healed within the follow up period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing | The proportion of ulcers healed at three months | 3 months | 
| Reduction in ulcer size | The absolute reduction in ulcer size in square cm | 6 months | 
| Relative Reduction in ulcer size | Reduction in ulcer size as a percentage of original ulcer area | 6 months | 
| Wound Progress | Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT) | 6 months | 
| Change in overall venous disease | Monthly change in Venous Clinical Severity Score | 6 months | 
| Change in Venous disease related quality of Live | Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study | 6 months |