Venous UlcerAAVTIRSNCT04484168
Axial Ablation Versus Terminal Interruption of the Reflux Source
A study testing Terminal Interruption of the Reflux Source and Axial Ablation in people with Venous Ulcer, run by University College Hospital Galway at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Terminal Interruption of the Reflux Source and Axial Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteIreland
- Study dates
- 21 Jul 2020to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Roscommon Unversity Hospiral
Roscommon
Colum R Keohane, MB BCh BAO, 00353876492372, columkeohane@rcsi.ie
About this study
Official title: 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.
- Conditions
- Venous Ulcer
- Being tested
- Terminal Interruption of the Reflux Source, Axial Ablation
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terminal Interruption of the Reflux SourceProcedure or surgery
Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
Axial AblationProcedure or surgery
Endovenous ablation of venous reflux in the main superficial veins of the leg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Axial Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing
The main outcome measure is the proportion of ulcers which have healed within the follow up period
Measured: 6 months
Secondary outcomes (6)
Ulcer Healing
The proportion of ulcers healed at three months
Measured: 3 months
Reduction in ulcer size
The absolute reduction in ulcer size in square cm
Measured: 6 months
Relative Reduction in ulcer size
Reduction in ulcer size as a percentage of original ulcer area
Measured: 6 months
Wound Progress
Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)
Measured: 6 months
Change in overall venous disease
Monthly change in Venous Clinical Severity Score
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start21 Jul 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Collaborators
- Stewart R Walsh, Wael Tawfick, Thomas A Aherne, Mark Twyford, Marie O'Shaughnessy
- Responsible party
- Principal investigator, Colum Keohane, University College Hospital Galway
- Investigators
- Colum R Keohane, MB,BCh,BAO, Principal investigator, UCH Galway and NUI Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484168
- Sponsor's protocol ID
- CA2416
- Acronym
- AAVTIRS
- Status last verified
- May 2022
- First submitted
- 20 Jul 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39034428Keohane 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.
PubMed 35689289
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04484168
- Acronym / sponsor ID
- AAVTIRS / CA2416
- Conditions
- Venous Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Collaborators
- Stewart R Walsh, Wael Tawfick, Thomas A Aherne, Mark Twyford, Marie O'Shaughnessy
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terminal Interruption of the Reflux Source (TIRS | Active comparator | Procedure: Terminal Interruption of the Reflux SourceThese 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 |
| Axial Ablation | Active comparator | Procedure: Axial AblationThese patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terminal Interruption of the Reflux SourceFoam Sclerotherapy of veins in the immediate vicinity of the venous ulcer | Procedure or surgery | Terminal Interruption of the Reflux Source (TIRS |
| Axial AblationEndovenous ablation of venous reflux in the main superficial veins of the leg | Procedure or surgery | Axial Ablation |
Primary outcome
Ulcer healing
Time frame: 6 months
The main outcome measure is the proportion of ulcers which have healed within the follow up period
6 secondary outcomes
Ulcer Healing
Time frame: 3 months
Reduction in ulcer size
Time frame: 6 months
Relative Reduction in ulcer size
Time frame: 6 months
Wound Progress
Time frame: 6 months
Change in overall venous disease
Time frame: 6 months
Change in Venous disease related quality of Live
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 39034428Cr 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.
- Derived from this study: PubMed 35689289Keohane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colum R Keohane, MB,BCh,BAO principal investigator
UCH Galway and NUI Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terminal Interruption of the Reflux Source and Axial Ablation in people with Venous Ulcer, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colum R Keohane, MB,BCh,BAO (00353876492372, columkeohane@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.