<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/NCT03795064</url>
  </required_header>
  <id_info>
    <org_study_id>268/2018</org_study_id>
    <nct_id>NCT03795064</nct_id>
  </id_info>
  <brief_title>Immediate Versus Early Endovenous Ablation In Venous Ulcer</brief_title>
  <official_title>Immediate Versus Early Endovenous Ablation In Venous Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oulu University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is conducted to assess the effects of immediately started foam sclerotherapy in&#xD;
      venous ulcer compared to early intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or&#xD;
      endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled&#xD;
      trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit&#xD;
      to vascular outpatient clinic (immediate intervention). Patients in control group will&#xD;
      receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is&#xD;
      performed in early setting in both groups when truncal vein anatomy is suitable. The primary&#xD;
      outcome for this study is the reduction of venous ulcer area at four weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Venous ulcer area</measure>
    <time_frame>0 to 180 days</time_frame>
    <description>Venous ulcer area measured from calibrated digital photograph.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to ulcer healing</measure>
    <time_frame>0 to 360 days</time_frame>
    <description>Complete re-epithelialisation of ulcer area.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total time of active venous ulcer</measure>
    <time_frame>0 to 360 days</time_frame>
    <description>Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Venous Ulcer</condition>
  <arm_group>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Foam sclerotherapy</intervention_name>
    <description>Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.</description>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_label>Immediate Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endothermal ablation</intervention_name>
    <description>Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.</description>
    <arm_group_label>Early Intervention</arm_group_label>
    <arm_group_label>Immediate Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Venous ulcer &gt; 1 month&#xD;
&#xD;
          -  Ulcer area &gt; 1cm2&#xD;
&#xD;
          -  Palpable distal pulses / Ankle-brachial index &gt; 0,8 / Toe-brachial index &gt; 70mmhg (at&#xD;
             least one criteria must be met)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Leg ulcers other than venous etiology&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  General contraindications for foam sclerotherapy&#xD;
&#xD;
          -  Ulcers requiring operation theater revision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oulu University Hospital, Vascular Department</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oulu University Hospital</investigator_affiliation>
    <investigator_full_name>Toni Pihlaja</investigator_full_name>
    <investigator_title>Vascular Specialist</investigator_title>
  </responsible_party>
  <keyword>Venous Ulcer</keyword>
  <keyword>Venous Insufficiency of Leg</keyword>
  <keyword>Varicose Veins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03795064
org study id: 268/2018
nct id: NCT03795064
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is conducted to assess the effects of immediately started foam sclerotherapy in
      venous ulcer compared to early intervention.
Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or
      endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled
      trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit
      to vascular outpatient clinic (immediate intervention). Patients in control group will
      receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is
      performed in early setting in both groups when truncal vein anatomy is suitable. The primary
      outcome for this study is the reduction of venous ulcer area at four weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Venous ulcer area
time frame: 0 to 180 days
description: Venous ulcer area measured from calibrated digital photograph.
measure: Time to ulcer healing
time frame: 0 to 360 days
description: Complete re-epithelialisation of ulcer area.
measure: Total time of active venous ulcer
time frame: 0 to 360 days
description: Time from when ulcer was first time noticed to complete re-epithelialisation of ulcer area.
arm group label: Immediate Intervention
arm group type: Experimental
description: Patients in this group will be treated with foam sclerotherapy immediately in the first visit to outpatient clinic (immediate intervention).
arm group label: Early Intervention
arm group type: Active Comparator
description: Patients in this group will be treated with foam sclerotherapy in the following visit to outpatient clinic at four weeks (early intervention).
intervention type: Procedure
intervention name: Foam sclerotherapy
description: Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
arm group label: Early Intervention
arm group label: Immediate Intervention
intervention type: Procedure
intervention name: Endothermal ablation
description: Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
arm group label: Early Intervention
arm group label: Immediate Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Oulu University Hospital
investigator full name: Toni Pihlaja
investigator title: Vascular Specialist
mesh term: Varicose Ulcer
mesh term: Ulcer
sharing ipd: No