<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484168</url>
  </required_header>
  <id_info>
    <org_study_id>CA2416</org_study_id>
    <nct_id>NCT04484168</nct_id>
  </id_info>
  <brief_title>Axial Ablation Versus Terminal Interruption of the Reflux Source</brief_title>
  <acronym>AAVTIRS</acronym>
  <official_title>Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Hospital Galway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stewart R Walsh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wael Tawfick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thomas A Aherne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mark Twyford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marie O'Shaughnessy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College Hospital Galway</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised trial aims to compare the effect on ulcer healing of different means of&#xD;
      managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous&#xD;
      ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus&#xD;
      terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will&#xD;
      be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of&#xD;
      the ulcer being treated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer healing</measure>
    <time_frame>6 months</time_frame>
    <description>The main outcome measure is the proportion of ulcers which have healed within the follow up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ulcer Healing</measure>
    <time_frame>3 months</time_frame>
    <description>The proportion of ulcers healed at three months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in ulcer size</measure>
    <time_frame>6 months</time_frame>
    <description>The absolute reduction in ulcer size in square cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Reduction in ulcer size</measure>
    <time_frame>6 months</time_frame>
    <description>Reduction in ulcer size as a percentage of original ulcer area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Progress</measure>
    <time_frame>6 months</time_frame>
    <description>Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall venous disease</measure>
    <time_frame>6 months</time_frame>
    <description>Monthly change in Venous Clinical Severity Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Venous disease related quality of Live</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">308</enrollment>
  <condition>Venous Ulcer</condition>
  <arm_group>
    <arm_group_label>Terminal Interruption of the Reflux Source (TIRS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Axial Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Terminal Interruption of the Reflux Source</intervention_name>
    <description>Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer</description>
    <arm_group_label>Terminal Interruption of the Reflux Source (TIRS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Axial Ablation</intervention_name>
    <description>Endovenous ablation of venous reflux in the main superficial veins of the leg</description>
    <arm_group_label>Axial Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Primary or recurrent venous leg ulcer&#xD;
&#xD;
        Long or short saphenous vein reflux confirmed on ultrasound assessment, defined as&#xD;
        retrograde flow lasting for &gt;0.5 seconds&#xD;
&#xD;
        Ankle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial&#xD;
        Index(TBI) ≥ 0.5 acceptable), or a palpable pulse&#xD;
&#xD;
        Ulcer size between 1 and 200 cm2&#xD;
&#xD;
        Patient suitable for full compression bandaging&#xD;
&#xD;
        Exclusion criteria Pregnancy (or breastfeeding and needing to feed within 48 hours of&#xD;
        treatment)&#xD;
&#xD;
        Active infection of ulcer, or infection within the last two weeks&#xD;
&#xD;
        Leg ulcer of non-venous aetiology as determined by clinical assessment&#xD;
&#xD;
        Isolated perforator vein reflux only&#xD;
&#xD;
        Evidence of deep venous insufficiency or thrombosis&#xD;
&#xD;
        Known hypersensitivity to Sotradecol or similar sclerosants&#xD;
&#xD;
        Previous inability to tolerate compression bandages&#xD;
&#xD;
        Presence of any contraindications for the use of compression bandages:&#xD;
&#xD;
        Absence of a palpable pulse, and Ankle Brachial Index (ABI) &lt;0.8&#xD;
&#xD;
        Decompensated congestive cardiac failure (NYHA Class IV)&#xD;
&#xD;
        Known hypersensitivity to any of the component materials&#xD;
&#xD;
        Patients unable to provide informed consent&#xD;
&#xD;
        Patients attending the leg ulcer clinic already will be excluded from enrolment with the&#xD;
        same ulcer but will be eligible to enrol with a contralateral ulcer. Recurrent ipsilateral&#xD;
        ulcers will not be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colum R Keohane, MB,BCh,BAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCH Galway and NUI Galway</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colum R Keohane, MB,BCh,BAO</last_name>
    <phone>00353876492372</phone>
    <email>columkeohane@rcsi.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stewart R Walsh, MCh,MD</last_name>
    <phone>0035391893642</phone>
    <email>stewartredmond.walsh@nuigalway.ie</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Roscommon Unversity Hospiral</name>
      <address>
        <city>Roscommon</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colum R Keohane, MB BCh BAO</last_name>
      <phone>00353876492372</phone>
      <email>columkeohane@rcsi.ie</email>
    </contact>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Hospital Galway</investigator_affiliation>
    <investigator_full_name>Colum Keohane</investigator_full_name>
    <investigator_title>Specialist Registrar in Vascular Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484168
org study id: CA2416
nct id: NCT04484168
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Ulcer healing
time frame: 6 months
description: The main outcome measure is the proportion of ulcers which have healed within the follow up period
measure: Ulcer Healing
time frame: 3 months
description: The proportion of ulcers healed at three months
measure: Reduction in ulcer size
time frame: 6 months
description: The absolute reduction in ulcer size in square cm
measure: Relative Reduction in ulcer size
time frame: 6 months
description: Reduction in ulcer size as a percentage of original ulcer area
measure: Wound Progress
time frame: 6 months
description: Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)
measure: Change in overall venous disease
time frame: 6 months
description: Monthly change in Venous Clinical Severity Score
measure: Change in Venous disease related quality of Live
time frame: 6 months
description: Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study
arm group label: Terminal Interruption of the Reflux Source (TIRS
arm group type: Active Comparator
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 group label: Axial Ablation
arm group type: Active Comparator
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: Terminal Interruption of the Reflux Source
description: Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
arm group label: Terminal Interruption of the Reflux Source (TIRS
intervention type: Procedure
intervention name: Axial Ablation
description: Endovenous ablation of venous reflux in the main superficial veins of the leg
arm group label: Axial Ablation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Colum R Keohane, MB,BCh,BAO
role: Principal Investigator
affiliation: UCH Galway and NUI Galway
last name: Colum R Keohane, MB,BCh,BAO
phone: 00353876492372
email: columkeohane@rcsi.ie
last name: Stewart R Walsh, MCh,MD
phone: 0035391893642
email: stewartredmond.walsh@nuigalway.ie
facility: 
status: Recruiting
contact: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University College Hospital Galway
investigator full name: Colum Keohane
investigator title: Specialist Registrar in Vascular Surgery
mesh term: Varicose Ulcer
sharing ipd: No