<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/NCT03010319</url>
  </required_header>
  <id_info>
    <org_study_id>T-PMXDFU-001</org_study_id>
    <nct_id>NCT03010319</nct_id>
  </id_info>
  <brief_title>PriMatrix for the Management of Diabetic Foot Ulcers</brief_title>
  <official_title>Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Integra LifeSciences Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of&#xD;
      diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care&#xD;
      treatment. Half of patients will be treated using PriMatrix while the other half will receive&#xD;
      Standard of Care treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of&#xD;
      individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely&#xD;
      challenging as these ulcers may not respond to standard of care (SC) treatment and frequently&#xD;
      become infected.&#xD;
&#xD;
      Advanced wound therapies like PriMatrix have become an important strategy in the treatment of&#xD;
      hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the&#xD;
      dermis layer of the skin to aid in healing.&#xD;
&#xD;
      The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of&#xD;
      DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 2020</completion_date>
  <primary_completion_date type="Actual">August 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase</measure>
    <time_frame>12-week Treatment Phase</time_frame>
    <description>Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase</measure>
    <time_frame>12-week treatment phase</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Wound Closure, as Assessed by the Investigator</measure>
    <time_frame>12-week Treatment Phase</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Wound Closure, as Assessed by Computerized Planimetry.</measure>
    <time_frame>12-week Treatment Phase</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Wound Closure, as Assessed by Computerized Planimetry.</measure>
    <time_frame>Weeks 1-12 during Treatment Phase</time_frame>
    <description>Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.&#xD;
NOTE1: Rate (% closed/week) = 7 * [(Baseline wound size) - (Post-baseline wound size)]/[(Baseline wound size) * (days in trial)] NOTE2: Missing data is imputed using LOCF method for this analysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>PriMatrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PriMatrix Dermal Repair Scaffold</intervention_name>
    <description>Application of PriMatrix to ulcer</description>
    <arm_group_label>PriMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Secondary Dressings</intervention_name>
    <description>Dressings to ensure moist wound environment</description>
    <arm_group_label>PriMatrix</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Offloading device</intervention_name>
    <description>Offloading device to decrease pressure to wound area</description>
    <arm_group_label>PriMatrix</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subjects are required to meet all of the following criteria for enrollment into the study&#xD;
        and subsequent randomization:&#xD;
&#xD;
          1. The subject has signed and dated an informed consent form.&#xD;
&#xD;
          2. In the opinion of the investigator, subject is able and willing to comply with study&#xD;
             procedures, including study visits, study dressing regimens and compliance with study&#xD;
             required off-loading device.&#xD;
&#xD;
          3. The subject is ≥ 18 years of age.&#xD;
&#xD;
          4. The subject, if female of child-bearing potential, must not be pregnant. To document&#xD;
             pregnancy status, subject statement is acceptable.&#xD;
&#xD;
          5. The subject has Type I or Type II diabetes mellitus with investigator-confirmed&#xD;
             glycosylated hemoglobin (HbA1c) of ≤ 12% within 3 months prior to screening visit.&#xD;
&#xD;
          6. The subject has at least one diabetic foot ulcer that meets ALL of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Ulcer which has been in existence for a minimum of two weeks, prior to signing&#xD;
                  the Informed Consent Form for trial participation.&#xD;
&#xD;
               -  Ulcer is a partial or full thickness diabetic foot ulcer without&#xD;
                  capsule/tendon/bone exposure.&#xD;
&#xD;
               -  Ulcer does not have tunneling, undermining, or sinus tracts that necessitates&#xD;
                  surgical OR debridement and/or penetrates to capsule/tendon/bone.&#xD;
&#xD;
               -  Ulcer is located on the foot or ankle (with no portion above the top of the&#xD;
                  malleolus).&#xD;
&#xD;
               -  Ulcer size (area) is &gt; 1 cm2 and &lt; 12 cm2 post-debridement.&#xD;
&#xD;
          7. There is a minimum 1 cm margin between the qualifying study ulcer and any other ulcer&#xD;
             on that same foot, post-debridement.&#xD;
&#xD;
             • If the subject has more than one ulcer that meets the eligibility criteria, the&#xD;
             ulcer designated as the study ulcer will be at the discretion of the investigator.&#xD;
&#xD;
          8. The subject has adequate vascular perfusion of the affected limb as defined by at&#xD;
             least one of the following:&#xD;
&#xD;
               -  Ankle-Brachial Index (ABI) ≥ 0.65 or ≤1.2, performed within 3 months of&#xD;
                  screening,&#xD;
&#xD;
               -  Toe pressure (plethysmography) &gt; 50 mmHg at time of screening,&#xD;
&#xD;
               -  TcPO2 &gt; 40 mmHg at time of screening&#xD;
&#xD;
          9. The subject or responsible caregiver is willing and able to maintain required&#xD;
             applicable dressing changes as well as study required off-loading/protective device&#xD;
             for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects will not be enrolled in the study if any of the following criteria are met:&#xD;
&#xD;
          1. The subject was previously randomized and treated under this clinical study protocol.&#xD;
&#xD;
          2. The subject has suspected or confirmed gangrene or ulcer infection of the study ulcer&#xD;
             or receiving systemic antibiotics for the treatment of such.&#xD;
&#xD;
          3. The subject has suspected or confirmed osteomyelitis of the foot with the study ulcer.&#xD;
&#xD;
          4. The subject has a history of hypersensitivity to bovine collagen, as determined by&#xD;
             prior medical history.&#xD;
&#xD;
             Protocol Number: T-PMXDFU-01 Confidential Page 23 of 64 Version 5.0 06 Nov 2018&#xD;
&#xD;
          5. The subject has participated in another clinical trial involving a device or a&#xD;
             systemically administered investigational study drug/treatment within 28 days of&#xD;
             randomization.&#xD;
&#xD;
          6. The subject has received, within 28 of signing Informed Consent Form, or is scheduled&#xD;
             to receive during study participation, a medication or treatment which is known to&#xD;
             interfere with or affect the rate and quality of ulcer healing (e.g., systemic&#xD;
             steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation&#xD;
             therapy to the foot, vascular surgery, angioplasty, or thrombolysis).&#xD;
&#xD;
          7. The subject has a history of bone cancer or metastatic disease of the affected limb,&#xD;
             radiation therapy to the foot, or has had chemotherapy within the 12 months prior to&#xD;
             signing Informed Consent Form for trial participation.&#xD;
&#xD;
          8. In the opinion of the investigator, the subject has a history of, or is currently&#xD;
             diagnosed with, any illness or condition, other than diabetes, that could interfere&#xD;
             with ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease,&#xD;
             aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV&#xD;
             positive, or sickle cell anemia).&#xD;
&#xD;
          9. In the opinion of the investigator, the subject has unstable Charcot foot or Charcot&#xD;
             with bony prominence that could inhibit ulcer healing.&#xD;
&#xD;
         10. The subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis,&#xD;
             neoplasms, or hematological disorders).&#xD;
&#xD;
         11. In the opinion of the investigator, the subject has excessive lymphedema that could&#xD;
             interfere with off-loading and/or ulcer healing.&#xD;
&#xD;
         12. The study ulcer has received ulcer dressings that included growth factors, engineered&#xD;
             tissues, or skin substitutes within 28 days of randomization or is scheduled to&#xD;
             receive treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix,&#xD;
             GraftJacket, OASIS, Omnigraft, or Integra BMWD).&#xD;
&#xD;
         13. At the end of the screening phase and based on planimetric assessment, the area of the&#xD;
             study ulcer after sharp debridement has decreased by more than 30% over the two-week&#xD;
             screening period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Lantis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Mount Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ILD Research Center</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Foot &amp; Ankle Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research, Inc.</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Valley Vein and Wound</name>
      <address>
        <city>Selma</city>
        <state>California</state>
        <zip>93662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barry University Clinical Research</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Podiatry Group</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podiatry 1st</name>
      <address>
        <city>Belleville</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wound Care of Tulsa</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martin Foot and Ankle</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podiatric Medical Partners of Texas, P.A.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JPS Health Network</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futuro Clinical Trials</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Element Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</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>April 2022</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>January 24, 2022</results_first_submitted>
  <results_first_submitted_qc>March 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2022</results_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</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>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Patient Data will not be shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03010319/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03010319/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PriMatrix</title>
          <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor requested withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Primary Efficacy Population</population>
      <group_list>
        <group group_id="B1">
          <title>PriMatrix</title>
          <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</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="103"/>
            <count group_id="B2" value="104"/>
            <count group_id="B3" value="207"/>
          </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="58.5" spread="11.92"/>
                    <measurement group_id="B2" value="57.6" spread="11.49"/>
                    <measurement group_id="B3" value="58.0" spread="11.69"/>
                  </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="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="163"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase</title>
        <description>Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.</description>
        <time_frame>12-week Treatment Phase</time_frame>
        <population>Primary Efficacy Population</population>
        <group_list>
          <group group_id="O1">
            <title>PriMatrix</title>
            <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase</title>
          <description>Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.</description>
          <population>Primary Efficacy Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase</title>
        <time_frame>12-week treatment phase</time_frame>
        <population>Primary Efficacy Population</population>
        <group_list>
          <group group_id="O1">
            <title>PriMatrix</title>
            <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase</title>
          <population>Primary Efficacy Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Wound Closure, as Assessed by the Investigator</title>
        <time_frame>12-week Treatment Phase</time_frame>
        <population>Primary Efficacy Population with Complete Wound Closure</population>
        <group_list>
          <group group_id="O1">
            <title>PriMatrix</title>
            <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Wound Closure, as Assessed by the Investigator</title>
          <population>Primary Efficacy Population with Complete Wound Closure</population>
          <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="47"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.6" spread="21.39"/>
                    <measurement group_id="O2" value="56.2" spread="18.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Wound Closure, as Assessed by Computerized Planimetry.</title>
        <time_frame>12-week Treatment Phase</time_frame>
        <population>Primary Efficacy Population with Complete Wound Closure</population>
        <group_list>
          <group group_id="O1">
            <title>PriMatrix</title>
            <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Wound Closure, as Assessed by Computerized Planimetry.</title>
          <population>Primary Efficacy Population with Complete Wound Closure</population>
          <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="36"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.8" spread="20.63"/>
                    <measurement group_id="O2" value="56.8" spread="16.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Wound Closure, as Assessed by Computerized Planimetry.</title>
        <description>Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.&#xD;
NOTE1: Rate (% closed/week) = 7 * [(Baseline wound size) - (Post-baseline wound size)]/[(Baseline wound size) * (days in trial)] NOTE2: Missing data is imputed using LOCF method for this analysis</description>
        <time_frame>Weeks 1-12 during Treatment Phase</time_frame>
        <population>Primary Efficacy Population</population>
        <group_list>
          <group group_id="O1">
            <title>PriMatrix</title>
            <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Wound Closure, as Assessed by Computerized Planimetry.</title>
          <description>Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.&#xD;
NOTE1: Rate (% closed/week) = 7 * [(Baseline wound size) - (Post-baseline wound size)]/[(Baseline wound size) * (days in trial)] NOTE2: Missing data is imputed using LOCF method for this analysis</description>
          <population>Primary Efficacy Population</population>
          <units>Percentage of Wound Closed/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="103"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.727" spread="7.142"/>
                    <measurement group_id="O2" value="0.996" spread="8.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.722" spread="9.446"/>
                    <measurement group_id="O2" value="1.999" spread="9.366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.587" spread="10.082"/>
                    <measurement group_id="O2" value="2.524" spread="9.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.443" spread="9.376"/>
                    <measurement group_id="O2" value="2.990" spread="9.653"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.603" spread="9.371"/>
                    <measurement group_id="O2" value="3.476" spread="9.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.764" spread="9.441"/>
                    <measurement group_id="O2" value="3.279" spread="9.951"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.054" spread="9.402"/>
                    <measurement group_id="O2" value="3.308" spread="10.072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.017" spread="9.759"/>
                    <measurement group_id="O2" value="3.632" spread="10.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.213" spread="9.554"/>
                    <measurement group_id="O2" value="3.820" spread="10.184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.970" spread="10.230"/>
                    <measurement group_id="O2" value="3.896" spread="10.184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.558" spread="9.480"/>
                    <measurement group_id="O2" value="3.837" spread="10.186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.637" spread="9.513"/>
                    <measurement group_id="O2" value="3.928" spread="10.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events data was collected from Screening Visit 2 through a potential Four-Week Post Wound Closure Visit, for a total of up to 17 weeks.</time_frame>
      <desc>Adverse Event Reporting population is the Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>PriMatrix</title>
          <description>Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.&#xD;
PriMatrix Dermal Repair Scaffold: Application of PriMatrix to ulcer&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.&#xD;
Secondary Dressings: Dressings to ensure moist wound environment&#xD;
Offloading device: Offloading device to decrease pressure to wound area</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <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="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Urinary Track Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </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="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Shock hypoglycemic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Coronary artery bypass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Foot amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Metatarsal excision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Peripheral ischemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <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="16" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="116"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diabetic Foot Infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="116"/>
              </event>
              <event>
                <sub_title>Diabetic Foot</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="110"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="116"/>
              </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>Investigators are barred from publishing or disclosing results until a multicenter publication is published or until a period of 24 months after study completion passes, whichever comes first.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Andrew Tummon Director, Global Clinical Affairs</name_or_title>
      <organization>Integra LifeSciences</organization>
      <phone>609-936-5490</phone>
      <email>andrew.tummon@integralife.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/NCT03010319
org study id: T-PMXDFU-001
nct id: NCT03010319
lead sponsor: 
has dmc: No
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of
      diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care
      treatment. Half of patients will be treated using PriMatrix while the other half will receive
      Standard of Care treatment.
A diabetic foot ulcer (DFU) is a major health complication that affects up to 15% of
      individuals with diabetes mellitus over their lifetime. The treatment of DFUs is extremely
      challenging as these ulcers may not respond to standard of care (SC) treatment and frequently
      become infected.

      Advanced wound therapies like PriMatrix have become an important strategy in the treatment of
      hard-to-heal chronic DFUs by trapping and binding the patients' own cells to rebuild the
      dermis layer of the skin to aid in healing.

      The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the closure of
      DFUs in subjects with diabetes mellitus in comparison to Standard of Care treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects With Complete Wound Closure, as Assessed by the Investigator, at or Before Week 12 of the Treatment Phase
time frame: 12-week Treatment Phase
description: Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without detectable exudate, confirmed on 2 consecutive study visits 1 week apart.
measure: Percentage of Subjects With Complete Wound Closure, as Assessed by Computerized Planimetry, at or Before Week 12 of the Treatment Phase
time frame: 12-week treatment phase
measure: Time to Complete Wound Closure, as Assessed by the Investigator
time frame: 12-week Treatment Phase
measure: Time to Complete Wound Closure, as Assessed by Computerized Planimetry.
time frame: 12-week Treatment Phase
measure: Rate of Wound Closure, as Assessed by Computerized Planimetry.
time frame: Weeks 1-12 during Treatment Phase
description: Rate of Wound closure was recorded as the percentage of the wound that was closed, per week.
NOTE1: Rate (% closed/week) = 7 * [(Baseline wound size) - (Post-baseline wound size)]/[(Baseline wound size) * (days in trial)] NOTE2: Missing data is imputed using LOCF method for this analysis
arm group label: PriMatrix
arm group type: Experimental
description: Arm will receive PriMatrix Dermal Repair Scaffold plus secondary dressings to maintain a moist wound healing environment and an appropriate off-loading device.
arm group label: Standard of Care
arm group type: Active Comparator
description: Arm will receive moist wound therapy consisting of 0.9% Sodium Chloride gel plus secondary dressings and an appropriate off-loading device.
intervention type: Device
intervention name: PriMatrix Dermal Repair Scaffold
description: Application of PriMatrix to ulcer
arm group label: PriMatrix
intervention type: Device
intervention name: Secondary Dressings
description: Dressings to ensure moist wound environment
arm group label: PriMatrix
arm group label: Standard of Care
intervention type: Device
intervention name: Offloading device
description: Offloading device to decrease pressure to wound area
arm group label: PriMatrix
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Lantis, MD
role: Principal Investigator
affiliation: The Mount Sinai Medical Center
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country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No
ipd description: Individual Patient Data will not be shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 