<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/NCT01729286</url>
  </required_header>
  <id_info>
    <org_study_id>TEI-007</org_study_id>
    <nct_id>NCT01729286</nct_id>
  </id_info>
  <brief_title>Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix</brief_title>
  <acronym>HEALED</acronym>
  <official_title>A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic 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 objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy&#xD;
      (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects&#xD;
      with diabetes mellitus and without significantly compromised arterial circulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a multi-center, prospective, randomized single-blinded study evaluating&#xD;
      the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure&#xD;
      of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and&#xD;
      changes in functional quality of life, each subject will complete the Cardiff Wound Impact&#xD;
      Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii)&#xD;
      at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the&#xD;
      data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete wound closure</measure>
    <time_frame>by 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in predicted medical expenditures between PriMatrix and Standard of Care</measure>
    <time_frame>over 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life measurements between PriMatrix and Standard of Care</measure>
    <time_frame>between baseline and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nonserious and serious adverse events</measure>
    <time_frame>over 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Foot Ulcer, Diabetic</condition>
  <arm_group>
    <arm_group_label>PriMatrix Moist Wound Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Moist Wound Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PriMatrix Moist Wound Therapy</intervention_name>
    <description>sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading</description>
    <arm_group_label>PriMatrix Moist Wound Therapy</arm_group_label>
    <other_name>PriMatrix Dermal Repair Scaffold</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care Moist Wound Therapy</intervention_name>
    <description>sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading</description>
    <arm_group_label>PriMatrix Moist Wound Therapy</arm_group_label>
    <arm_group_label>Standard of Care Moist Wound Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type I or Type II diabetes&#xD;
&#xD;
          -  A diabetic foot ulcer located on the foot or ankle at least one square centimeter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed signs/symptoms of wound infection&#xD;
&#xD;
          -  Hypersensitivity to bovine collagen&#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 Starinski, DPM</last_name>
    <role>Study Chair</role>
    <affiliation>TEI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Foot &amp; Ankle Specialists</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joseph M. Still Research Foundation</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot &amp; Andle Center of Mooresville</name>
      <address>
        <city>Mooresville</city>
        <state>Indiana</state>
        <zip>46158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial Health</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Vascular</name>
      <address>
        <city>North Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Anthony's Medical Center</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Long Island Jewish Comprehensive Wound Healing Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield Medical Center</name>
      <address>
        <city>Lancaster</city>
        <state>Ohio</state>
        <zip>43130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Podiatrico del Norte</name>
      <address>
        <city>Arecibo</city>
        <zip>00612</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renier Gonzalez-Cruz</name>
      <address>
        <city>Juana Diaz</city>
        <zip>00795</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Carribean Healthcare System</name>
      <address>
        <city>San Juan</city>
        <zip>00921</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</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>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01729286
org study id: TEI-007
nct id: NCT01729286
lead sponsor: 
has dmc: No
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy
      (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects
      with diabetes mellitus and without significantly compromised arterial circulation.
This study will be a multi-center, prospective, randomized single-blinded study evaluating
      the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure
      of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and
      changes in functional quality of life, each subject will complete the Cardiff Wound Impact
      Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii)
      at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the
      data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Complete wound closure
time frame: by 12 weeks
measure: Change in predicted medical expenditures between PriMatrix and Standard of Care
time frame: over 24 weeks
measure: Change in quality of life measurements between PriMatrix and Standard of Care
time frame: between baseline and 24 weeks
measure: Nonserious and serious adverse events
time frame: over 24 weeks
arm group label: PriMatrix Moist Wound Therapy
arm group type: Active Comparator
description: sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
arm group label: Standard of Care Moist Wound Therapy
arm group type: Other
description: sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
intervention type: Device
intervention name: PriMatrix Moist Wound Therapy
description: sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
arm group label: PriMatrix Moist Wound Therapy
other name: PriMatrix Dermal Repair Scaffold
intervention type: Other
intervention name: Standard of Care Moist Wound Therapy
description: sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
arm group label: PriMatrix Moist Wound Therapy
arm group label: Standard of Care Moist Wound Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Starinski, DPM
role: Study Chair
affiliation: TEI
facility: 
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No