<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/NCT03257254</url>
  </required_header>
  <id_info>
    <org_study_id>BTG-001652-01</org_study_id>
    <nct_id>NCT03257254</nct_id>
  </id_info>
  <brief_title>Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)</brief_title>
  <acronym>VIEW-VLU</acronym>
  <official_title>Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 12 month, multicenter, open-label registry to observe chronic venous insufficiency&#xD;
      resulting in VLU treated with Varithena.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This 12 month, multicenter, open-label registry is designed to collect treatment and outcome&#xD;
      data related to participants treated with Varithena for great saphenous vein (GSV) system&#xD;
      and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant&#xD;
      are treated per Investigator's Standard of Care (SoC) and in accordance with the Full&#xD;
      Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed&#xD;
      ulcers during the 12 month follow-up period, VLU recurrence information is collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 18, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change From Baseline in Wound Perimeter</measure>
    <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
    <description>Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Wound Closure at 12 Weeks</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
    <description>Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Wound Closure</measure>
    <time_frame>Baseline to wound closure or to 12 months, whichever occurs first</time_frame>
    <description>Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain</measure>
    <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
    <description>Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;10&quot;. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on EQ-5D-5L Quality of Life Assessment</measure>
    <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
    <description>Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;1&quot;. Higher score mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VCSS</measure>
    <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
    <description>Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of &quot;0&quot; and maximum score of &quot;3&quot;. The individual items are added together to assess change from baseline. Higher scores mean worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Wound Recurrences</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Ulcer Free Days</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Mean number of ulcer free days defined as days from baseline to date of recurrence</description>
  </secondary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Venous Leg Ulcer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varithena</intervention_name>
    <description>Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP)&#xD;
        classification with active VLU resulting from venous insufficiency of the GSV system and/or&#xD;
        AASV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women; age ≥18&#xD;
&#xD;
          -  Investigator has selected Varithena® to treat participants classified C6 with chronic&#xD;
             (≥3 months) VLU resulting from GSV and/or AASV incompetence&#xD;
&#xD;
          -  Wound can be visualized in one plane to allow for image collection of the entire wound&#xD;
             in one photograph, or if wound is circumferential, participant must be able to capture&#xD;
             the entire wound using multiple photographs taken from directly above the wound&#xD;
             (straight on)&#xD;
&#xD;
          -  Reflux &gt;500 milliseconds (ms) on duplex ultrasound&#xD;
&#xD;
          -  Willing and able to collect wound photographs and data using an application installed&#xD;
             on a tablet&#xD;
&#xD;
          -  Willing and able to return for scheduled follow-up and wound care visits&#xD;
&#xD;
          -  Ability to comprehend and sign informed consent form (ICF) and complete questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to Varithena® 1% in accordance with the FPI&#xD;
&#xD;
          -  Any serious concomitant disease, per physician's discretion, that confounds wound&#xD;
             healing, including malignant changes of wound&#xD;
&#xD;
          -  Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to&#xD;
             treatment with Varithena®&#xD;
&#xD;
          -  Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8&#xD;
&#xD;
          -  In the opinion of Investigator, wound would close within 12 weeks without additional&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michael Shao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Covenant Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vascular Experts</name>
      <address>
        <city>Darien</city>
        <state>Connecticut</state>
        <zip>06820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pines Clinical Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Covenant Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass General, Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Venous Institute of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Cincinnati -West Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Totality</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Sciences Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Washington Vascular, PLLC</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakville Vascular</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6J7S2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>September 28, 2021</results_first_submitted>
  <results_first_submitted_qc>November 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2021</results_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GSV</keyword>
  <keyword>AASV</keyword>
  <keyword>Vein</keyword>
  <keyword>Venous</keyword>
  <keyword>Ulcer</keyword>
  <keyword>Varicose Vein</keyword>
  <keyword>VLU</keyword>
  <keyword>venous insufficiency</keyword>
  <keyword>venous disease</keyword>
  <keyword>chronic VLU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Venous Insufficiency</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polidocanol</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03257254/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT03257254/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prospective Registry Cohort</title>
          <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study discontinued by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prospective Registry Cohort</title>
          <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="76"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.6" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Wound Perimeter</title>
        <description>Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.</description>
        <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
        <population>Based on number of wounds continuing to heal at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Wound Perimeter</title>
          <description>Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.</description>
          <population>Based on number of wounds continuing to heal at the timepoint.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.36" spread="146.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.64" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Wound Closure at 12 Weeks</title>
        <description>Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.</description>
        <time_frame>Baseline to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Wound Closure at 12 Weeks</title>
          <description>Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.</description>
          <units>wounds</units>
          <param>Number</param>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Wound Closure</title>
        <description>Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.</description>
        <time_frame>Baseline to wound closure or to 12 months, whichever occurs first</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Wound Closure</title>
          <description>Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="62" upper_limit="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain</title>
        <description>Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;10&quot;. Higher scores mean a worse outcome.</description>
        <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
        <population>Analysis is based on the number of wounds and not number of patients. If a patient had more than one reported pain score during a timepoint, the worst (highest) NPRS score was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain</title>
          <description>Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;10&quot;. Higher scores mean a worse outcome.</description>
          <population>Analysis is based on the number of wounds and not number of patients. If a patient had more than one reported pain score during a timepoint, the worst (highest) NPRS score was used for analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change on EQ-5D-5L Quality of Life Assessment</title>
        <description>Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;1&quot;. Higher score mean better outcome.</description>
        <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
        <population>Statistics are based on the number of wounds and not number of patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Change on EQ-5D-5L Quality of Life Assessment</title>
          <description>Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is &quot;0&quot; and maximum value is &quot;1&quot;. Higher score mean better outcome.</description>
          <population>Statistics are based on the number of wounds and not number of patients.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.066" spread="0.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.072" spread="0.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in VCSS</title>
        <description>Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of &quot;0&quot; and maximum score of &quot;3&quot;. The individual items are added together to assess change from baseline. Higher scores mean worst outcome.</description>
        <time_frame>Baseline to 12 weeks and to 12 months</time_frame>
        <population>Analysis is based on number of wounds and not number of patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in VCSS</title>
          <description>Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of &quot;0&quot; and maximum score of &quot;3&quot;. The individual items are added together to assess change from baseline. Higher scores mean worst outcome.</description>
          <population>Analysis is based on number of wounds and not number of patients.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>at 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date</title>
        <description>Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>54 wounds were closed prior to the 12-month follow up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date</title>
          <description>Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.</description>
          <population>54 wounds were closed prior to the 12-month follow up visit.</population>
          <units>wounds</units>
          <param>Count of Units</param>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Wound Recurrences</title>
        <description>Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>54 wounds were closed prior to the 12 month follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Wound Recurrences</title>
          <description>Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.</description>
          <population>54 wounds were closed prior to the 12 month follow up.</population>
          <units>wounds</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>wounds</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>wounds</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5.4" upper_limit="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Ulcer Free Days</title>
        <description>Mean number of ulcer free days defined as days from baseline to date of recurrence</description>
        <time_frame>Baseline to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Registry Cohort</title>
            <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Ulcer Free Days</title>
          <description>Mean number of ulcer free days defined as days from baseline to date of recurrence</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240.5" spread="118.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during a 1 year period starting from the initiation of treatment until the subject completes the registry follow up period or withdraws.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prospective Registry Cohort</title>
          <description>Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Toe amputation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Polyarteritis nodosa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Timothy Keo</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>425-599-3814</phone>
      <email>Timothy.Keo@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03257254
org study id: BTG-001652-01
nct id: NCT03257254
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency
      resulting in VLU treated with Varithena.
This 12 month, multicenter, open-label registry is designed to collect treatment and outcome
      data related to participants treated with Varithena for great saphenous vein (GSV) system
      and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant
      are treated per Investigator's Standard of Care (SoC) and in accordance with the Full
      Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed
      ulcers during the 12 month follow-up period, VLU recurrence information is collected.
observational model: Cohort
time perspective: Prospective
measure: Change From Baseline in Wound Perimeter
time frame: Baseline to 12 weeks and to 12 months
description: Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.
measure: Number of Wound Closure at 12 Weeks
time frame: Baseline to 12 weeks
description: Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
measure: Time to Wound Closure
time frame: Baseline to wound closure or to 12 months, whichever occurs first
description: Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.
measure: Change in Pain
time frame: Baseline to 12 weeks and to 12 months
description: Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome.
measure: Change on EQ-5D-5L Quality of Life Assessment
time frame: Baseline to 12 weeks and to 12 months
description: Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome.
measure: Change in VCSS
time frame: Baseline to 12 weeks and to 12 months
description: Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome.
measure: Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date
time frame: Baseline to 12 months
description: Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.
measure: Number of Wound Recurrences
time frame: Baseline to 12 months
description: Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.
measure: Number of Ulcer Free Days
time frame: Baseline to 12 months
description: Mean number of ulcer free days defined as days from baseline to date of recurrence
intervention type: Drug
intervention name: Varithena
description: Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Michael Shao, MD
role: Principal Investigator
affiliation: Swedish Covenant Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Venous Insufficiency
mesh term: Leg Ulcer
mesh term: Ulcer
mesh term: Polidocanol
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 