Axial Ablation Versus Terminal Interruption of the Reflux Source

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-10-31

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.

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Detailed Description

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Conditions

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Venous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Terminal Interruption of the Reflux Source (TIRS

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

Group Type ACTIVE_COMPARATOR

Terminal Interruption of the Reflux Source

Intervention Type PROCEDURE

Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer

Axial Ablation

These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux

Group Type ACTIVE_COMPARATOR

Axial Ablation

Intervention Type PROCEDURE

Endovenous ablation of venous reflux in the main superficial veins of the leg

Interventions

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Terminal Interruption of the Reflux Source

Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer

Intervention Type PROCEDURE

Axial Ablation

Endovenous ablation of venous reflux in the main superficial veins of the leg

Intervention Type PROCEDURE

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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No