Axial Ablation Versus Terminal Interruption of the Reflux Source

NCT04484168 | Unknown

• 1 other identifier: CA2416
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Ulcer

Outcome Measures

Primary Outcomes (1)

• Ulcer healing

  The main outcome measure is the proportion of ulcers which have healed within the follow up period

  6 months

Secondary Outcomes (6)

• Ulcer Healing

  3 months

• Reduction in ulcer size

  6 months

• Relative Reduction in ulcer size

  6 months

• Wound Progress

  6 months

• Change in overall venous disease

  6 months

Study Arms (2)

Terminal Interruption of the Reflux Source (TIRS

ACTIVE COMPARATOR

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

Axial Ablation

ACTIVE COMPARATOR

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

Procedure: Axial Ablation

Interventions

Terminal Interruption of the Reflux Source PROCEDURE

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

Terminal Interruption of the Reflux Source (TIRS

Axial Ablation PROCEDURE

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

Axial Ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Hospital Galway: lead
• Stewart R Walsh: collaborator
• Wael Tawfick: collaborator
• Thomas A Aherne: collaborator
• Mark Twyford: collaborator
• Marie O'Shaughnessy: collaborator

Study Sites (1)

Roscommon Unversity Hospiral

Roscommon, Ireland

RECRUITING

Related Publications (2)

• Cr K, D W, M T, T A, W T, Sr W. Axial Ablation versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial. Vasc Endovascular Surg. 2024 Nov;58(8):805-812. doi: 10.1177/15385744241265750. Epub 2024 Jul 21.

  PMID: 39034428 DERIVED

• Keohane CR, Westby D, Twyford M, Ahern T, Tawfick W, Walsh SR. Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial. Trials. 2022 Jun 10;23(1):483. doi: 10.1186/s13063-022-06440-4.

  PMID: 35689289 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Colum R Keohane, MB,BCh,BAO

  UCH Galway and NUI Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colum R Keohane, MB,BCh,BAO

CONTACT

00353876492372; columkeohane@rcsi.ie

Stewart R Walsh, MCh,MD

CONTACT

0035391893642; stewartredmond.walsh@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Vascular Surgery

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: July 21, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)