<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/NCT03020446</url>
  </required_header>
  <id_info>
    <org_study_id>Sorbion Study</org_study_id>
    <nct_id>NCT03020446</nct_id>
  </id_info>
  <brief_title>Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements</brief_title>
  <acronym>Sorbion</acronym>
  <official_title>Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toledo Health Science Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toledo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg&#xD;
      ulcers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wounds will be assessed for inclusion into the study, digital images of the wound will be&#xD;
      taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover&#xD;
      dressing with be used to keep in place. The wound will be assessed and a dressing change will&#xD;
      take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Provider of product no longer wished to continue with site. No data available.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound Size</measure>
    <time_frame>4 weeks</time_frame>
    <description>decreased wound bed measured in centimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound Maceration</measure>
    <time_frame>4 weeks</time_frame>
    <description>visual assessment of decreased wound maceration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Necrosis</measure>
    <time_frame>4 weeks</time_frame>
    <description>visual assessment of decreased wound necrosis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Venous Wound Ulcers</condition>
  <arm_group>
    <arm_group_label>Sorbion dressing to venous leg ulcer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sorbion Dressing</intervention_name>
    <description>Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
    <arm_group_label>Sorbion dressing to venous leg ulcer</arm_group_label>
    <other_name>Sorbion Sachet sorbion sana</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  venous leg ulcer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant females&#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>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 7, 2015</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>November 3, 2020</results_first_submitted>
  <results_first_submitted_qc>November 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2020</results_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sorbion Dressing to Venous Leg Ulcer</title>
          <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sorbion Dressing to Venous Leg Ulcer</title>
          <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="62" upper_limit="76"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Wound Size</title>
        <description>decreased wound bed measured in centimeters</description>
        <time_frame>4 weeks</time_frame>
        <population>Study was terminated</population>
        <group_list>
          <group group_id="O1">
            <title>Sorbion Dressing to Venous Leg Ulcer</title>
            <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Size</title>
          <description>decreased wound bed measured in centimeters</description>
          <population>Study was terminated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wound Maceration</title>
        <description>visual assessment of decreased wound maceration</description>
        <time_frame>4 weeks</time_frame>
        <population>Study was termininated</population>
        <group_list>
          <group group_id="O1">
            <title>Sorbion Dressing to Venous Leg Ulcer</title>
            <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Maceration</title>
          <description>visual assessment of decreased wound maceration</description>
          <population>Study was termininated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wound Necrosis</title>
        <description>visual assessment of decreased wound necrosis</description>
        <time_frame>4 weeks</time_frame>
        <population>Study was terminated</population>
        <group_list>
          <group group_id="O1">
            <title>Sorbion Dressing to Venous Leg Ulcer</title>
            <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Necrosis</title>
          <description>visual assessment of decreased wound necrosis</description>
          <population>Study was terminated</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sorbion Dressing to Venous Leg Ulcer</title>
          <description>any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed&#xD;
Sorbion Dressing: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <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="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Munier Nazzal, MD</name_or_title>
      <organization>University of Toledo</organization>
      <phone>419-383-3576</phone>
      <email>Munier.Nazzal@utoledo.edu</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/NCT03020446
org study id: Sorbion Study
nct id: NCT03020446
lead sponsor: 
has dmc: No
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg
      ulcers.
Wounds will be assessed for inclusion into the study, digital images of the wound will be
      taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover
      dressing with be used to keep in place. The wound will be assessed and a dressing change will
      take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound Size
time frame: 4 weeks
description: decreased wound bed measured in centimeters
measure: Wound Maceration
time frame: 4 weeks
description: visual assessment of decreased wound maceration
measure: Wound Necrosis
time frame: 4 weeks
description: visual assessment of decreased wound necrosis
arm group label: Sorbion dressing to venous leg ulcer
arm group type: Experimental
description: any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed
intervention type: Device
intervention name: Sorbion Dressing
description: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
arm group label: Sorbion dressing to venous leg ulcer
other name: Sorbion Sachet sorbion sana
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Ulcer
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 