<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/NCT04405765</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0293</org_study_id>
    <nct_id>NCT04405765</nct_id>
  </id_info>
  <brief_title>Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds</brief_title>
  <official_title>Prospective, Randomized, Single-Center Study to Compare Clinical Outcomes Between Cryopreserved and Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osiris Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare&#xD;
      lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening&#xD;
&#xD;
      1. Explain purpose and nature of the study and obtain signature on the informed consent&#xD;
      document.&#xD;
&#xD;
      2. Screen the subject against protocol inclusion and exclusion criteria, including all&#xD;
      pertinent tests, including pregnancy test 3. Complete SF-36, EuroQol 5 dimensions (EQ-5D) and&#xD;
      PROMIS® Baseline (may be done as same day as screening procedures or within +2 days of&#xD;
      screening and before start of Therapy/Treatment Phase)&#xD;
&#xD;
        1. Obtain general medical history and demographic information and social history&#xD;
&#xD;
        2. Complete a physical examination, body weight, height, and vital signs, including&#xD;
           measurement of resting heart rate, respiratory rate, and blood pressure while seated.&#xD;
&#xD;
        3. Select target study ulcer&#xD;
&#xD;
        4. Obtain complete history pertinent to DFU disease including duration of the target ulcer,&#xD;
           previous and current treatment. Document ulcer classification.&#xD;
&#xD;
        5. Perform debridement and obtain tissue collection (3 tissue and 1 bone).&#xD;
&#xD;
        6. Perform standardized photography and measurement of the study wound (eKare or available&#xD;
           camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and&#xD;
           greatest depth (cm) using the inSight device (eKare, Fairfax, VA). These values are the&#xD;
           baseline measurements for calculating wound closure rate at the two-week run-in visit.&#xD;
&#xD;
        7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.&#xD;
&#xD;
        8. Perform neuropathy assessment&#xD;
&#xD;
        9. Collect all relevant concomitant medication (antibiotics, antifungals and other&#xD;
           anti-infective therapies)&#xD;
&#xD;
       10. Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy.&#xD;
&#xD;
       11. Document size of Stravix used.&#xD;
&#xD;
       12. Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days)&#xD;
&#xD;
      Study Visit 1-11:&#xD;
&#xD;
        1. Assess target ulcer (if wound has closed, document as such, skip to step 5).&#xD;
&#xD;
        2. Document time on/off NPWT if applicable.&#xD;
&#xD;
        3. Perform standardized photography of the study wound when NPWT is removed.&#xD;
&#xD;
        4. If Stravix is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth&#xD;
           (cm) using the inSight device - if the wound is deemed closed by the physician, skip to&#xD;
           EOS visit.&#xD;
&#xD;
        5. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is&#xD;
           active or closed.&#xD;
&#xD;
        6. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior&#xD;
           to dressing the wound.&#xD;
&#xD;
        7. Collect all relevant concomitant medication.&#xD;
&#xD;
        8. If wound is still active, redress the wound with assigned Stravix (if removed for&#xD;
           debridement) and NPWT. Document all dressings applied including size of Stravix.&#xD;
&#xD;
        9. Disburse subject stipend&#xD;
&#xD;
       10. Note: at week 4, if wound is not ready for grafting, remove existing Stravix and replace&#xD;
           with new piece of Stravix (per randomization schedule)&#xD;
&#xD;
       11. Assess for AE/SAEs and/or follow up on previous AE/SAEs.&#xD;
&#xD;
      Study Visit Closed 1. When a subject's study wound has closed, they will perform the EOS&#xD;
      evaluation.&#xD;
&#xD;
      Study Visit 12/EOS:&#xD;
&#xD;
        1. At the time of wound closure, subjects will perform EOS visit.&#xD;
&#xD;
        2. A subject whose wound is not deemed closed (epithelialized with no drainage) by&#xD;
           physician at week 12 will exit from the study after the week 12 wound evaluation.&#xD;
&#xD;
        3. Assess index ulcer.&#xD;
&#xD;
        4. If wound has not closed, perform standardized photography of the study wound.&#xD;
&#xD;
        5. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth&#xD;
           (cm) using the inSight device.&#xD;
&#xD;
        6. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is&#xD;
           active or healed.&#xD;
&#xD;
        7. If wound has not closed, redress the wound per physician-directed standard of care.&#xD;
&#xD;
        8. Administer Patient Reported Outcome (PRO) (questionnaires).&#xD;
&#xD;
        9. Collect all relevant concomitant medication&#xD;
&#xD;
       10. Perform EOS visit documentation&#xD;
&#xD;
       11. Follow up on AE/SAEs that have been reported that have not yet been resolved.&#xD;
&#xD;
      Study Visit Follow-up:&#xD;
&#xD;
      1. If the wound heals during the treatment phase or if the wound is not healed after 12&#xD;
      weeks, data from their electronic medical record will be evaluated to identify healing, time&#xD;
      to heal, adverse events related to the wound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2021</start_date>
  <completion_date type="Actual">July 7, 2022</completion_date>
  <primary_completion_date type="Actual">July 7, 2022</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Prospective, 2-arm parallel assignment, randomized clinical trial. Stravix will be applied at initial visit with NPWT and will only be reapplied after 4 weeks if wound is not ready for grafting unless debridement is indicated.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Wound Closure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients who achieve wound closure (complete epithelialization with no drainage)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Negative Pressure Wound Therapy</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of days patient received negative pressure wound therapy after application of Stravix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Split Thickness Skin Grafting</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients who received a split thickness skin graft</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients who developed infection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Diabetic Wound</condition>
  <arm_group>
    <arm_group_label>Lyopreserved Stravix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with NPWT and lyopreserved Stravix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cryopreserved Stravix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with NPWT and cryopreserved Stravix</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NPWT and lyopreserved Stravix</intervention_name>
    <description>Subjects will be treated with NPWT and lyopreserved Stravix</description>
    <arm_group_label>Lyopreserved Stravix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NPWT and cryopreserved Stravix</intervention_name>
    <description>Subjects will be treated with NPWT and lyopreserved Stravix</description>
    <arm_group_label>Cryopreserved Stravix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a diabetes mellitus&#xD;
&#xD;
          -  Men/women ≥21 years old&#xD;
&#xD;
          -  Post-operative foot or ankle wounds sized &gt;4cm2 that have presented for &lt;1 year&#xD;
&#xD;
          -  ABI ≥0.5 or toe pressures &gt;30 mmHg&#xD;
&#xD;
          -  Wounds indicated for treatment with NPWT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Charcot arthropy&#xD;
&#xD;
          -  Unable to use NPWT at home&#xD;
&#xD;
          -  Untreated bone or soft tissue infection&#xD;
&#xD;
          -  Is pregnant or plans to become pregnant&#xD;
&#xD;
          -  Is nursing or actively lactating&#xD;
&#xD;
          -  Developmental disability/significant psychological disorder that in the opinion of the&#xD;
             investigator could impair the subject's ability to provide informed consent,&#xD;
             participate in the study protocol or record study measures, including untreated&#xD;
             schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2&#xD;
             years.&#xD;
&#xD;
          -  Active alcohol or substance abuse in the opinion of the investigator that could impair&#xD;
             the subject's ability to provide informed consent, participate in the study protocol&#xD;
             or record study materials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lawrence Lavery, DPM MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>April 26, 2023</results_first_submitted>
  <results_first_submitted_qc>April 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2023</results_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Larry Lavery</investigator_full_name>
    <investigator_title>Professor and Director of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04405765/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lyopreserved Stravix</title>
          <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
        </group>
        <group group_id="P2">
          <title>Cryopreserved Stravix</title>
          <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lyopreserved Stravix</title>
          <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
        </group>
        <group group_id="B2">
          <title>Cryopreserved Stravix</title>
          <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.5" spread="11.5"/>
                    <measurement group_id="B2" value="55.4" spread="6.4"/>
                    <measurement group_id="B3" value="52.85" spread="9.7"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Wound Closure</title>
        <description>Number of patients who achieve wound closure (complete epithelialization with no drainage)</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lyopreserved Stravix</title>
            <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
          <group group_id="O2">
            <title>Cryopreserved Stravix</title>
            <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Wound Closure</title>
          <description>Number of patients who achieve wound closure (complete epithelialization with no drainage)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Negative Pressure Wound Therapy</title>
        <description>Number of days patient received negative pressure wound therapy after application of Stravix</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lyopreserved Stravix</title>
            <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
          <group group_id="O2">
            <title>Cryopreserved Stravix</title>
            <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Negative Pressure Wound Therapy</title>
          <description>Number of days patient received negative pressure wound therapy after application of Stravix</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.88" spread="5.96"/>
                    <measurement group_id="O2" value="4.66" spread="2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Split Thickness Skin Grafting</title>
        <description>Number of patients who received a split thickness skin graft</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lyopreserved Stravix</title>
            <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
          <group group_id="O2">
            <title>Cryopreserved Stravix</title>
            <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
        </group_list>
        <measure>
          <title>Split Thickness Skin Grafting</title>
          <description>Number of patients who received a split thickness skin graft</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Infection</title>
        <description>Number of patients who developed infection</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lyopreserved Stravix</title>
            <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
          <group group_id="O2">
            <title>Cryopreserved Stravix</title>
            <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
          </group>
        </group_list>
        <measure>
          <title>Infection</title>
          <description>Number of patients who developed infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lyopreserved Stravix</title>
          <description>Treated with NPWT and lyopreserved Stravix&#xD;
NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</description>
        </group>
        <group group_id="E2">
          <title>Cryopreserved Stravix</title>
          <description>Treated with NPWT and cryopreserved Stravix&#xD;
NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix</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="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital admission for non-foot reason</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital admission for foot infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infection of study wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </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>Tara Kristof - research coordinator</name_or_title>
      <organization>University of Texas Southwestern Medical Center</organization>
      <phone>214-648-9007</phone>
      <email>tara.kristof@utsouthwestern.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/NCT04405765
org study id: 2020-0293
nct id: NCT04405765
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare
      lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
Screening

      1. Explain purpose and nature of the study and obtain signature on the informed consent
      document.

      2. Screen the subject against protocol inclusion and exclusion criteria, including all
      pertinent tests, including pregnancy test 3. Complete SF-36, EuroQol 5 dimensions (EQ-5D) and
      PROMIS® Baseline (may be done as same day as screening procedures or within +2 days of
      screening and before start of Therapy/Treatment Phase)

        1. Obtain general medical history and demographic information and social history

        2. Complete a physical examination, body weight, height, and vital signs, including
           measurement of resting heart rate, respiratory rate, and blood pressure while seated.

        3. Select target study ulcer

        4. Obtain complete history pertinent to DFU disease including duration of the target ulcer,
           previous and current treatment. Document ulcer classification.

        5. Perform debridement and obtain tissue collection (3 tissue and 1 bone).

        6. Perform standardized photography and measurement of the study wound (eKare or available
           camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and
           greatest depth (cm) using the inSight device (eKare, Fairfax, VA). These values are the
           baseline measurements for calculating wound closure rate at the two-week run-in visit.

        7. Perform hyperspectral imaging of dorsal and plantar aspects of the foot.

        8. Perform neuropathy assessment

        9. Collect all relevant concomitant medication (antibiotics, antifungals and other
           anti-infective therapies)

       10. Place Stravix (lyo or cryo per randomization schedule) and dress wound for NPWT therapy.

       11. Document size of Stravix used.

       12. Disburse subject stipend Therapy/Treatment Phase (Weekly visits +/- 4 days)

      Study Visit 1-11:

        1. Assess target ulcer (if wound has closed, document as such, skip to step 5).

        2. Document time on/off NPWT if applicable.

        3. Perform standardized photography of the study wound when NPWT is removed.

        4. If Stravix is removed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
           (cm) using the inSight device - if the wound is deemed closed by the physician, skip to
           EOS visit.

        5. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
           active or closed.

        6. Debride wound if indicated. Re-measure wound if surgical debridement is performed prior
           to dressing the wound.

        7. Collect all relevant concomitant medication.

        8. If wound is still active, redress the wound with assigned Stravix (if removed for
           debridement) and NPWT. Document all dressings applied including size of Stravix.

        9. Disburse subject stipend

       10. Note: at week 4, if wound is not ready for grafting, remove existing Stravix and replace
           with new piece of Stravix (per randomization schedule)

       11. Assess for AE/SAEs and/or follow up on previous AE/SAEs.

      Study Visit Closed 1. When a subject's study wound has closed, they will perform the EOS
      evaluation.

      Study Visit 12/EOS:

        1. At the time of wound closure, subjects will perform EOS visit.

        2. A subject whose wound is not deemed closed (epithelialized with no drainage) by
           physician at week 12 will exit from the study after the week 12 wound evaluation.

        3. Assess index ulcer.

        4. If wound has not closed, perform standardized photography of the study wound.

        5. If wound has not closed, assess the ulcer area (cm2), perimeter (cm), and greatest depth
           (cm) using the inSight device.

        6. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot if wound is
           active or healed.

        7. If wound has not closed, redress the wound per physician-directed standard of care.

        8. Administer Patient Reported Outcome (PRO) (questionnaires).

        9. Collect all relevant concomitant medication

       10. Perform EOS visit documentation

       11. Follow up on AE/SAEs that have been reported that have not yet been resolved.

      Study Visit Follow-up:

      1. If the wound heals during the treatment phase or if the wound is not healed after 12
      weeks, data from their electronic medical record will be evaluated to identify healing, time
      to heal, adverse events related to the wound.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, 2-arm parallel assignment, randomized clinical trial. Stravix will be applied at initial visit with NPWT and will only be reapplied after 4 weeks if wound is not ready for grafting unless debridement is indicated.
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Wound Closure
time frame: 12 weeks
description: Number of patients who achieve wound closure (complete epithelialization with no drainage)
measure: Duration of Negative Pressure Wound Therapy
time frame: 12 weeks
description: Number of days patient received negative pressure wound therapy after application of Stravix
measure: Split Thickness Skin Grafting
time frame: 12 weeks
description: Number of patients who received a split thickness skin graft
measure: Infection
time frame: 12 weeks
description: Number of patients who developed infection
arm group label: Lyopreserved Stravix
arm group type: Active Comparator
description: Treated with NPWT and lyopreserved Stravix
arm group label: Cryopreserved Stravix
arm group type: Active Comparator
description: Treated with NPWT and cryopreserved Stravix
intervention type: Device
intervention name: NPWT and lyopreserved Stravix
description: Subjects will be treated with NPWT and lyopreserved Stravix
arm group label: Lyopreserved Stravix
intervention type: Device
intervention name: NPWT and cryopreserved Stravix
description: Subjects will be treated with NPWT and lyopreserved Stravix
arm group label: Cryopreserved Stravix
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence Lavery, DPM MPH
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Larry Lavery
investigator title: Professor and Director of Research
mesh term: Wounds and Injuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 