Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 1:39 PM
Study NCT ID:
NCT04484168
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2020-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axial Ablation Versus Terminal Interruption of the Reflux Source
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ulcer healing', 'timeFrame': '6 months', 'description': 'The main outcome measure is the proportion of ulcers which have healed within the follow up period'}], 'secondaryOutcomes': [{'measure': 'Ulcer Healing', 'timeFrame': '3 months', 'description': 'The proportion of ulcers healed at three months'}, {'measure': 'Reduction in ulcer size', 'timeFrame': '6 months', 'description': 'The absolute reduction in ulcer size in square cm'}, {'measure': 'Relative Reduction in ulcer size', 'timeFrame': '6 months', 'description': 'Reduction in ulcer size as a percentage of original ulcer area'}, {'measure': 'Wound Progress', 'timeFrame': '6 months', 'description': 'Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)'}, {'measure': 'Change in overall venous disease', 'timeFrame': '6 months', 'description': 'Monthly change in Venous Clinical Severity Score'}, {'measure': 'Change in Venous disease related quality of Live', 'timeFrame': '6 months', 'description': 'Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Ulcer']}, 'referencesModule': {'references': [{'pmid': '39034428', 'type': 'DERIVED', 'citation': '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': '35689289', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPrimary or recurrent venous leg ulcer\n\nLong or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for \\>0.5 seconds\n\nAnkle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial Index(TBI) ≥ 0.5 acceptable), or a palpable pulse\n\nUlcer size between 1 and 200 cm2\n\nPatient suitable for full compression bandaging\n\nExclusion criteria Pregnancy (or breastfeeding and needing to feed within 48 hours of treatment)\n\nActive infection of ulcer, or infection within the last two weeks\n\nLeg ulcer of non-venous aetiology as determined by clinical assessment\n\nIsolated perforator vein reflux only\n\nEvidence of deep venous insufficiency or thrombosis\n\nKnown hypersensitivity to Sotradecol or similar sclerosants\n\nPrevious inability to tolerate compression bandages\n\nPresence of any contraindications for the use of compression bandages:\n\nAbsence of a palpable pulse, and Ankle Brachial Index (ABI) \\<0.8\n\nDecompensated congestive cardiac failure (NYHA Class IV)\n\nKnown hypersensitivity to any of the component materials\n\nPatients unable to provide informed consent\n\nPatients 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.'}, 'identificationModule': {'nctId': 'NCT04484168', 'acronym': 'AAVTIRS', 'briefTitle': 'Axial Ablation Versus Terminal Interruption of the Reflux Source', 'organization': {'class': 'OTHER', 'fullName': 'University College Hospital Galway'}, 'officialTitle': 'Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CA2416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Terminal Interruption of the Reflux Source (TIRS', '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', 'interventionNames': ['Procedure: Terminal Interruption of the Reflux Source']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Axial Ablation', 'description': 'These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux', 'interventionNames': ['Procedure: Axial Ablation']}], 'interventions': [{'name': 'Terminal Interruption of the Reflux Source', 'type': 'PROCEDURE', 'description': 'Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer', 'armGroupLabels': ['Terminal Interruption of the Reflux Source (TIRS']}, {'name': 'Axial Ablation', 'type': 'PROCEDURE', 'description': 'Endovenous ablation of venous reflux in the main superficial veins of the leg', 'armGroupLabels': ['Axial Ablation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roscommon', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Colum R Keohane, MB BCh BAO', 'role': 'CONTACT', 'email': 'columkeohane@rcsi.ie', 'phone': '00353876492372'}], 'facility': 'Roscommon Unversity Hospiral', 'geoPoint': {'lat': 53.63333, 'lon': -8.18333}}], 'centralContacts': [{'name': 'Colum R Keohane, MB,BCh,BAO', 'role': 'CONTACT', 'email': 'columkeohane@rcsi.ie', 'phone': '00353876492372'}, {'name': 'Stewart R Walsh, MCh,MD', 'role': 'CONTACT', 'email': 'stewartredmond.walsh@nuigalway.ie', 'phone': '0035391893642'}], 'overallOfficials': [{'name': 'Colum R Keohane, MB,BCh,BAO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCH Galway and NUI Galway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Hospital Galway', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stewart R Walsh', 'class': 'UNKNOWN'}, {'name': 'Wael Tawfick', 'class': 'UNKNOWN'}, {'name': 'Thomas A Aherne', 'class': 'UNKNOWN'}, {'name': 'Mark Twyford', 'class': 'UNKNOWN'}, {'name': "Marie O'Shaughnessy", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Registrar in Vascular Surgery', 'investigatorFullName': 'Colum Keohane', 'investigatorAffiliation': 'University College Hospital Galway'}}}}