<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/NCT03293836</url>
  </required_header>
  <id_info>
    <org_study_id>Vuert trial</org_study_id>
    <secondary_id>UTN</secondary_id>
    <nct_id>NCT03293836</nct_id>
  </id_info>
  <brief_title>Venous Ulcer: Endovenous Radiofrequency Treatment Trial</brief_title>
  <acronym>VUERT</acronym>
  <official_title>Venous Ulcer: Endovenous Radiofrequency Treatment of Insufficient Perforating and Saphenous Veins Versus Multilayer Compression Bandaging - Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juliana Puggina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for&#xD;
      superficial and perforating venous insufficiency versus compression therapy with multilayer&#xD;
      banding in patients with active venous ulcer. This is a controlled, randomized prospective&#xD;
      clinical trial. People with venous ulcers and primary venous insufficiency in superficial and&#xD;
      perforating venous system will be studied. Participants will be divided into two experimental&#xD;
      groups: compression therapy alone, and compression therapy associated with superficial and&#xD;
      perforating venous system ablation. Clinical aspects, improvement in patients' quality of&#xD;
      life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12&#xD;
      months after ulcer healing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer Healing - 12 w</measure>
    <time_frame>12 weeks</time_frame>
    <description>Ulcers was already healed after 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ulcer Healing - 24 w</measure>
    <time_frame>24 weeks</time_frame>
    <description>Ulcers was already healed after 24 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ulcer Recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Ulcer recurrence rate after 1 year of follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life SF-36</measure>
    <time_frame>at the begginning and up to 1 week after ulcer had healed</time_frame>
    <description>Increasing in individual's quality of life using SF 36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life EQ- 5D</measure>
    <time_frame>at the begginning and up to 1 week after ulcer had healed</time_frame>
    <description>Increasing in individual's quality of life using EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life VLU-Qol</measure>
    <time_frame>at the begginning and up to 1 week after ulcer had healed</time_frame>
    <description>Increasing in individual's quality of life using VLU-Qol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life CCVLUQ</measure>
    <time_frame>at the begginning and up to 1 week after ulcer had healed</time_frame>
    <description>Increasing in individual's quality of life using VLU-Qol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economic Assessment</measure>
    <time_frame>1 year</time_frame>
    <description>A cost-effectiveness analysis will be performed using the collected data of resources used in participants care along the study. Cost-utility (QALY) will be calculated using EQ-5d questionarie data</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Varicose Ulcer</condition>
  <condition>Varicose Veins of Lower Limb</condition>
  <condition>Saphenous Vein Injury</condition>
  <arm_group>
    <arm_group_label>Radiofrequency treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multilayer Compressive Bandage only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive only compressive treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <description>Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)</description>
    <arm_group_label>Radiofrequency treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multilayer Compressive Bandage</intervention_name>
    <description>Individual receive multilayer compressive bandage once a week</description>
    <arm_group_label>Multilayer Compressive Bandage only</arm_group_label>
    <arm_group_label>Radiofrequency treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 80 years old&#xD;
&#xD;
          -  venous ulcer appeared at least 4 weeks, bellow knee&#xD;
&#xD;
          -  ankle-brachial index more than 0.9&#xD;
&#xD;
          -  saphenous veins insufficiency plus perforating veins reflux&#xD;
&#xD;
          -  saphenous vein diameter between 5 mm and 12 mm&#xD;
&#xD;
          -  absence of saphenous veins thrombophlebitis&#xD;
&#xD;
          -  absence of personal history of venous deep thrombosis&#xD;
&#xD;
          -  absence of ultrasound evidence of actual or previous venous deep thrombosis&#xD;
&#xD;
          -  absence of severe ankle anquilosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unable to receive surgical intervention due to severe clinical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor R Sincos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juliana Puggina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juliana Puggina, MD</last_name>
    <phone>+5511988604601</phone>
    <email>juliana.puggina@usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Igor R Sincos, PhD</last_name>
    <phone>+5511984477382</phone>
    <email>igorsincos@usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (University of São Paulo)</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliana Puggina, MD</last_name>
      <phone>+5511988604601</phone>
      <email>juliana.puggina@usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Debora Nolli</last_name>
      <phone>+5511999707101</phone>
      <email>vuert.trial@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Juliana Puggina</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Varicose ulcer</keyword>
  <keyword>Venous ulcer</keyword>
  <keyword>Radiofrequency ablation</keyword>
  <keyword>Perforating veins insufficiency</keyword>
  <keyword>Varicose veins treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>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/NCT03293836
org study id: Vuert trial
secondary id: UTN
nct id: NCT03293836
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to analyze the effect of intravenous therapy with radiofrequency for
      superficial and perforating venous insufficiency versus compression therapy with multilayer
      banding in patients with active venous ulcer. This is a controlled, randomized prospective
      clinical trial. People with venous ulcers and primary venous insufficiency in superficial and
      perforating venous system will be studied. Participants will be divided into two experimental
      groups: compression therapy alone, and compression therapy associated with superficial and
      perforating venous system ablation. Clinical aspects, improvement in patients' quality of
      life and interventions cost-effectiveness will be analyzed. Patients will be followed for 12
      months after ulcer healing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Ulcer Healing - 12 w
time frame: 12 weeks
description: Ulcers was already healed after 12 weeks
measure: Ulcer Healing - 24 w
time frame: 24 weeks
description: Ulcers was already healed after 24 weeks
measure: Ulcer Recurrence
time frame: 1 year
description: Ulcer recurrence rate after 1 year of follow up
measure: Quality of life SF-36
time frame: at the begginning and up to 1 week after ulcer had healed
description: Increasing in individual's quality of life using SF 36
measure: Quality of life EQ- 5D
time frame: at the begginning and up to 1 week after ulcer had healed
description: Increasing in individual's quality of life using EQ-5D
measure: Quality of life VLU-Qol
time frame: at the begginning and up to 1 week after ulcer had healed
description: Increasing in individual's quality of life using VLU-Qol
measure: Quality of life CCVLUQ
time frame: at the begginning and up to 1 week after ulcer had healed
description: Increasing in individual's quality of life using VLU-Qol
measure: Health Economic Assessment
time frame: 1 year
description: A cost-effectiveness analysis will be performed using the collected data of resources used in participants care along the study. Cost-utility (QALY) will be calculated using EQ-5d questionarie data
arm group label: Radiofrequency treatment
arm group type: Experimental
description: Radiofrequency ablation of insufficient saphenous and perforating veins plus multilayer compressive bandage treatment
arm group label: Multilayer Compressive Bandage only
arm group type: Active Comparator
description: Receive only compressive treatment
intervention type: Procedure
intervention name: Radiofrequency ablation
description: Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
arm group label: Radiofrequency treatment
intervention type: Procedure
intervention name: Multilayer Compressive Bandage
description: Individual receive multilayer compressive bandage once a week
arm group label: Multilayer Compressive Bandage only
arm group label: Radiofrequency treatment
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Igor R Sincos, PhD
role: Principal Investigator
affiliation: University of São Paulo
last name: Juliana Puggina, MD
role: Principal Investigator
affiliation: University of São Paulo
last name: Juliana Puggina, MD
phone: +5511988604601
email: juliana.puggina@usp.br
last name: Igor R Sincos, PhD
phone: +5511984477382
email: igorsincos@usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Juliana Puggina
investigator title: MD
mesh term: Varicose Veins
mesh term: Varicose Ulcer
mesh term: Ulcer
sharing ipd: No