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| Name | Class |
|---|---|
| Stewart R Walsh | UNKNOWN |
| Wael Tawfick | UNKNOWN |
| Thomas A Aherne | UNKNOWN |
| Mark Twyford |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terminal Interruption of the Reflux Source | Procedure | Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer |
|
| 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 |
| 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 |
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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 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colum R Keohane, MB,BCh,BAO | Contact | 00353876492372 | columkeohane@rcsi.ie | |
| Stewart R Walsh, MCh,MD | Contact | 0035391893642 | stewartredmond.walsh@nuigalway.ie |
| Name | Affiliation | Role |
|---|---|---|
| Colum R Keohane, MB,BCh,BAO | UCH Galway and NUI Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roscommon Unversity Hospiral | Recruiting | Roscommon | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39034428 | Derived | 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. | |
| 35689289 | 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. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Marie O'Shaughnessy | UNKNOWN |
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| Axial Ablation | Procedure | Endovenous ablation of venous reflux in the main superficial veins of the leg |
|
| 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 |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |