Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Ulcer
• Intervention / Treatment: Procedure: Terminal Interruption of the Reflux Source; Procedure: Axial Ablation

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colum R Keohane, MB,BCh,BAO; Phone Number: 00353876492372; Email: columkeohane@rcsi.ie
• Study Contact Backup: Name: Stewart R Walsh, MCh,MD; Phone Number: 0035391893642; Email: stewartredmond.walsh@nuigalway.ie

Study Locations

• Ireland
  • Roscommon, Ireland
    • Recruiting
    • Roscommon Unversity Hospiral
    • Contact: Colum R Keohane, MB BCh BAO; Phone Number: 00353876492372; Email: columkeohane@rcsi.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College Hospital Galway
• Collaborators: Stewart R Walsh; Wael Tawfick; Thomas A Aherne; Mark Twyford; Marie O'Shaughnessy
• Investigators: Principal Investigator: Colum R Keohane, MB,BCh,BAO, UCH Galway and NUI Galway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer
• Other Study ID Numbers: CA2416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No