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

Primary Purpose

Venous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Terminal Interruption of the Reflux Source
Axial Ablation
Sponsored by
University College Hospital Galway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roscommon Unversity HospiralRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Terminal Interruption of the Reflux Source (TIRS

Axial Ablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2020
Last Updated
May 16, 2022
Sponsor
University College Hospital Galway
Collaborators
Stewart R Walsh, Wael Tawfick, Thomas A Aherne, Mark Twyford, Marie O'Shaughnessy
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1. Study Identification

Unique Protocol Identification Number
NCT04484168
Brief Title
Axial Ablation Versus Terminal Interruption of the Reflux Source
Acronym
AAVTIRS
Official Title
Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
Collaborators
Stewart R Walsh, Wael Tawfick, Thomas A Aherne, Mark Twyford, Marie O'Shaughnessy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Terminal Interruption of the Reflux Source (TIRS
Arm Type
Active Comparator
Arm Description
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
Arm Title
Axial Ablation
Arm Type
Active Comparator
Arm Description
These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux
Intervention Type
Procedure
Intervention Name(s)
Terminal Interruption of the Reflux Source
Intervention Description
Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
Intervention Type
Procedure
Intervention Name(s)
Axial Ablation
Intervention Description
Endovenous ablation of venous reflux in the main superficial veins of the leg
Primary Outcome Measure Information:
Title
Ulcer healing
Description
The main outcome measure is the proportion of ulcers which have healed within the follow up period
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ulcer Healing
Description
The proportion of ulcers healed at three months
Time Frame
3 months
Title
Reduction in ulcer size
Description
The absolute reduction in ulcer size in square cm
Time Frame
6 months
Title
Relative Reduction in ulcer size
Description
Reduction in ulcer size as a percentage of original ulcer area
Time Frame
6 months
Title
Wound Progress
Description
Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)
Time Frame
6 months
Title
Change in overall venous disease
Description
Monthly change in Venous Clinical Severity Score
Time Frame
6 months
Title
Change in Venous disease related quality of Live
Description
Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colum R Keohane, MB,BCh,BAO
Phone
00353876492372
Email
columkeohane@rcsi.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Stewart R Walsh, MCh,MD
Phone
0035391893642
Email
stewartredmond.walsh@nuigalway.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colum R Keohane, MB,BCh,BAO
Organizational Affiliation
UCH Galway and NUI Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roscommon Unversity Hospiral
City
Roscommon
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colum R Keohane, MB BCh BAO
Phone
00353876492372
Email
columkeohane@rcsi.ie

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35689289
Citation
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.
Results Reference
derived

Learn more about this trial

Axial Ablation Versus Terminal Interruption of the Reflux Source

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