<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/NCT03232333</url>
  </required_header>
  <id_info>
    <org_study_id>2016002</org_study_id>
    <nct_id>NCT03232333</nct_id>
  </id_info>
  <brief_title>MIRODERM H2H DFU Study</brief_title>
  <acronym>H2H-DFU</acronym>
  <official_title>Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miromatrix Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miromatrix Medical Inc.</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 will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within&#xD;
      12 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine the number of successful complete wound&#xD;
      closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some&#xD;
      secondary objectives of this study include documenting the time course of wound healing and&#xD;
      assessing changes in quality of life.&#xD;
&#xD;
      The primary cohort is individuals suffering from a diabetic foot ulcer that has not been&#xD;
      healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer&#xD;
      will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle,&#xD;
      and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes&#xD;
      with adequate vascular profusion. Subjects will be unable to participate if they have&#xD;
      osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are&#xD;
      immunocompromised or have an HbA1c level equal to or great than 12%.&#xD;
&#xD;
      This is a single-arm study with no Independent Variables. Descriptive data to be collected&#xD;
      will include demographics, pathology and medical history.&#xD;
&#xD;
      Outcome assessments:&#xD;
&#xD;
        -  proportion of subjects with 100% epithelialization of wound&#xD;
&#xD;
        -  SF-36&#xD;
&#xD;
        -  Adverse events&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Percentage of Participants</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage of participants with healed ulcers within 12 weeks of treatment</description>
  </primary_outcome>
  <other_outcome>
    <measure>MIRODERM Applications</measure>
    <time_frame>12 weeks</time_frame>
    <description>Frequency of MIRODERM applications prior to wound closing</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to Closure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measures the time from treatment to wound healing</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient's Wound Size</measure>
    <time_frame>12 weeks</time_frame>
    <description>Gives the mean area that the wound closed per week</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Form F36 - Physical Component Summary Score</measure>
    <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
    <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Form 36 - Mental Component Summary Score</measure>
    <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
    <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Form - 36: Bodily Pain</measure>
    <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
    <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>MIRODERM</arm_group_label>
    <description>Biologic wound graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biologic wound graft</intervention_name>
    <description>Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix</description>
    <arm_group_label>MIRODERM</arm_group_label>
    <other_name>MIRODERM Biologic Wound Matrix treatment</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Debridement waste&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have at least one small to moderately sized diabetic foot ulcer and have&#xD;
        been undergoing extended and unsuccessful treatment, as defined by failure of the wound to&#xD;
        completely close over the previous 3 months and after application of at least 2 biological&#xD;
        products.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older at time of initial visit&#xD;
&#xD;
          -  Have Type I or Type II diabetes&#xD;
&#xD;
          -  Have a neuropathic diabetic foot ulcer with the following characteristics:&#xD;
&#xD;
               -  Is greater than 1 cm2 and less than or equal to 12 cm2&#xD;
&#xD;
               -  Has failed to close following at least 2 treatments with a biologic&#xD;
&#xD;
               -  Has been present for 90 days or longer&#xD;
&#xD;
               -  Does not show signs of infection&#xD;
&#xD;
               -  Is full thickness (Wagner Grade I or II)&#xD;
&#xD;
               -  Located distal to the malleolus&#xD;
&#xD;
               -  Depth of less than or equal to 5 mm&#xD;
&#xD;
               -  No exposed capsule, tendon or bone&#xD;
&#xD;
               -  No tunneling, undermining or sinus tracts&#xD;
&#xD;
               -  Not between the toes&#xD;
&#xD;
          -  Be willing and able to maintain required off-loading of affected limb&#xD;
&#xD;
          -  Be willing and able to perform necessary dressing changes&#xD;
&#xD;
          -  Have at least one of the following:&#xD;
&#xD;
               -  An Ankle-brachial index (ABI) ≥ 0.8&#xD;
&#xD;
               -  TcPO2 of ≥ 30 mmHg&#xD;
&#xD;
               -  A toe pressure of ≥ 50 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be pregnant or be planning to become pregnant during the study&#xD;
&#xD;
          -  Have had a Chopart's Amputation (or higher)&#xD;
&#xD;
          -  Have a history of bone cancer of the affected limb&#xD;
&#xD;
          -  Be undergoing dialysis&#xD;
&#xD;
          -  Have active osteomyelitis or be receiving treatment for osteomyelitis&#xD;
&#xD;
          -  Be diagnosed with unstable Charcot Foot on the affected side&#xD;
&#xD;
          -  Have an HbA1c level of ≥ 12% within the past 90 days&#xD;
&#xD;
          -  Have another ulcer within 2 cm of the study ulcer&#xD;
&#xD;
          -  Be immunocompromised or at risk of immunosuppression as determined by the treating&#xD;
             investigator&#xD;
&#xD;
          -  Have a known collagen vascular disease or connective tissue disease&#xD;
&#xD;
          -  Have received treatment of the study ulcer with a skin substitute product or topical&#xD;
             growth factor within the past 4 weeks&#xD;
&#xD;
          -  Be participating in another medical research study&#xD;
&#xD;
          -  Have a sensitivity to porcine material&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Robert Fridman, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foot Associates of New York</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M Mason Macenski, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Miromatrix</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ILD Research</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bond Clinic / Clinical Reseach of Central Florida</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Institute of Podiatry</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Anthony's Wound Care Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A Step Ahead Foot Care</name>
      <address>
        <city>Mount Vernon</city>
        <state>New York</state>
        <zip>10550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gramercy Park Podiatry</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot Associates of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Institute</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>June 17, 2019</results_first_submitted>
  <results_first_submitted_qc>September 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2019</results_first_posted>
  <last_update_submitted>October 9, 2019</last_update_submitted>
  <last_update_submitted_qc>October 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</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>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>February 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03232333/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MIRODERM</title>
          <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Infection or Osteomyelitis</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MIRODERM</title>
          <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="9.2"/>
                  </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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>8 are hispanic</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="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.2" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>percentage of glycosylated hemoglobin</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.8" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ankle Brachial Index</title>
          <description>The Ankle Bronchial Index (ABI) is the systolic blood pressure reading obtained at the ankle divided by the systolic blood pressure reading from an arm. An ABI of 0.9 or may indicate peripheral vascular insufficiency. An ABI ratio between 1.0 and 1.4 is normal</description>
          <units>Ratio</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.02" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco Use</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 1 pack/day</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 1 pack/day</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol Use</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Occasional</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Monthly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Weekly</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Daily</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound Size Screening</title>
          <units>cm^2</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound Size Treatment</title>
          <units>cm^2</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound Age</title>
          <units>weeks</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.1" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Treatments</title>
          <units>Applications</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="2" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound Location</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="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Toes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Forefoot</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Midfoot</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Heel</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants</title>
        <description>Percentage of participants with healed ulcers within 12 weeks of treatment</description>
        <time_frame>12 weeks</time_frame>
        <population>Per protocol analysis</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants</title>
          <description>Percentage of participants with healed ulcers within 12 weeks of treatment</description>
          <population>Per protocol analysis</population>
          <units>Percentage of participants with healed u</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>MIRODERM Applications</title>
        <description>Frequency of MIRODERM applications prior to wound closing</description>
        <time_frame>12 weeks</time_frame>
        <population>Per protocol analysis</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>MIRODERM Applications</title>
          <description>Frequency of MIRODERM applications prior to wound closing</description>
          <population>Per protocol analysis</population>
          <units>Applications</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to Closure</title>
        <description>Measures the time from treatment to wound healing</description>
        <time_frame>12 weeks</time_frame>
        <population>Subjects who healed in 12 weeks or less</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Closure</title>
          <description>Measures the time from treatment to wound healing</description>
          <population>Subjects who healed in 12 weeks or less</population>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="2" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Patient's Wound Size</title>
        <description>Gives the mean area that the wound closed per week</description>
        <time_frame>12 weeks</time_frame>
        <population>Per protocol analysis</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient's Wound Size</title>
          <description>Gives the mean area that the wound closed per week</description>
          <population>Per protocol analysis</population>
          <units>cm^2 per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Short Form F36 - Physical Component Summary Score</title>
        <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.</description>
        <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
        <population>Subjects who's ulcer healed in 12 weeks or less two without appropriate data</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form F36 - Physical Component Summary Score</title>
          <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.</description>
          <population>Subjects who's ulcer healed in 12 weeks or less two without appropriate data</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.0" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.71</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Short Form 36 - Mental Component Summary Score</title>
        <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.</description>
        <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
        <population>Subjects who's wound healed in 12 weeks or less one without appropriate data</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form 36 - Mental Component Summary Score</title>
          <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.</description>
          <population>Subjects who's wound healed in 12 weeks or less one without appropriate data</population>
          <units>score on a scale</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.63</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Short Form - 36: Bodily Pain</title>
        <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.</description>
        <time_frame>Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)</time_frame>
        <population>Per protocol analysis</population>
        <group_list>
          <group group_id="O1">
            <title>MIRODERM</title>
            <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form - 36: Bodily Pain</title>
          <description>Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.</description>
          <population>Per protocol analysis</population>
          <units>score on a scale</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" spread="32.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=.01</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MIRODERM</title>
          <description>Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix</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="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ketoacidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </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="11" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Wound abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Increase in wound size</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </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>
    <limitations_and_caveats>Not a randomized trial</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Head of Clinical Affairs</name_or_title>
      <organization>Miromatrix</organization>
      <phone>952.942-6000</phone>
      <email>mmacenski@miromatrix.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/NCT03232333
org study id: 2016002
nct id: NCT03232333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within
      12 weeks of treatment.
The primary objective of this study is to determine the number of successful complete wound
      closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some
      secondary objectives of this study include documenting the time course of wound healing and
      assessing changes in quality of life.

      The primary cohort is individuals suffering from a diabetic foot ulcer that has not been
      healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer
      will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle,
      and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes
      with adequate vascular profusion. Subjects will be unable to participate if they have
      osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are
      immunocompromised or have an HbA1c level equal to or great than 12%.

      This is a single-arm study with no Independent Variables. Descriptive data to be collected
      will include demographics, pathology and medical history.

      Outcome assessments:

        -  proportion of subjects with 100% epithelialization of wound

        -  SF-36

        -  Adverse events
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants
time frame: 12 weeks
description: Percentage of participants with healed ulcers within 12 weeks of treatment
measure: MIRODERM Applications
time frame: 12 weeks
description: Frequency of MIRODERM applications prior to wound closing
measure: Time to Closure
time frame: 12 weeks
description: Measures the time from treatment to wound healing
measure: Change in Patient's Wound Size
time frame: 12 weeks
description: Gives the mean area that the wound closed per week
measure: Short Form F36 - Physical Component Summary Score
time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
description: Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.
measure: Short Form 36 - Mental Component Summary Score
time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
description: Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.
measure: Short Form - 36: Bodily Pain
time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
description: Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.
arm group label: MIRODERM
description: Biologic wound graft
intervention type: Device
intervention name: Biologic wound graft
description: Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix
arm group label: MIRODERM
other name: MIRODERM Biologic Wound Matrix treatment
Debridement waste
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Robert Fridman, DPM
role: Principal Investigator
affiliation: Foot Associates of New York
last name: M Mason Macenski, PhD
role: Study Director
affiliation: Miromatrix
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country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
sharing ipd: No
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Not a randomized trial
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