<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/NCT01693133</url>
  </required_header>
  <id_info>
    <org_study_id>EFDFU003</org_study_id>
    <nct_id>NCT01693133</nct_id>
  </id_info>
  <brief_title>Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers</brief_title>
  <official_title>A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MiMedx Group, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MiMedx Group, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the percentage of patients with complete diabetic&#xD;
      foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human&#xD;
      amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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 closure of the study ulcer</measure>
    <time_frame>Week 12</time_frame>
    <description>Assessed by the Investigator, during treatment (Visits 1 - 13).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to complete closure for both groups</measure>
    <time_frame>Up to 12 Weeks</time_frame>
    <description>As assessed by photographic evaluation and the Investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of wound closure</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>As assessed by photographic evaluation and the Investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ulcer recurrence</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness of treatment</measure>
    <time_frame>Up to Week 12</time_frame>
    <description>Cost effectiveness of treatment regimen.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>The Safety population will be used for the analysis of safety endpoints.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of Care: Moist Wound Therapy and Offloading</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EpiFix plus Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care: Moist Wound Therapy and Offloading</intervention_name>
    <description>Standard of Care: Moist Wound Therapy and Offloading</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EpiFix plus Standard of Care</intervention_name>
    <description>Weekly application of EpiFix and Standard of Care</description>
    <arm_group_label>EpiFix plus Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female age 18 or older.&#xD;
&#xD;
          2. The patient is willing and able to provide informed consent and participate in all&#xD;
             procedures and follow up evaluations necessary to complete the study.&#xD;
&#xD;
          3. Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2.&#xD;
             Debridement will be done prior to randomization, if clinically indicated.&#xD;
&#xD;
          4. Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the&#xD;
             foot.&#xD;
&#xD;
          5. Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus&#xD;
             per ADA).&#xD;
&#xD;
          6. Ulcer must be present for a minimum of 30 days before enrollment/randomization, with&#xD;
             documented failure of prior treatment to heal the wound (≤25% wound area reduction&#xD;
             after 14 consecutive days of therapy immediately prior to randomization when treated&#xD;
             with standard protocol of care).&#xD;
&#xD;
          7. Affected leg has been offloaded (removable walker or total contact cast) for &gt;14&#xD;
             consecutive days prior to randomization.&#xD;
&#xD;
          8. Serum Creatinine less than 3.0mg/dl (within last 6 months).&#xD;
&#xD;
          9. HbA1c less than 12% within previous 60 days.&#xD;
&#xD;
         10. Patient has adequate circulation to the affected extremity, as demonstrated by one of&#xD;
             the following within the past 60 days:&#xD;
&#xD;
               -  Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR&#xD;
&#xD;
               -  ABIs with results of ≥0.7 and ≤1.2, OR&#xD;
&#xD;
               -  Doppler arterial waveforms, which are triphasic or biphasic at the ankle of&#xD;
                  affected foot.&#xD;
&#xD;
         11. Females of childbearing potential must be willing to use acceptable methods of&#xD;
             contraception (birth control pills, barriers, or abstinence).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive&#xD;
             probe-tobone will be confirmed when bone or joint can be felt with a sterile,&#xD;
             ophthalmological probe.&#xD;
&#xD;
          2. Patients with multiple wounds on the same foot where other wounds are within 3 cm of&#xD;
             the wound under care.&#xD;
&#xD;
          3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or&#xD;
             greater at any time within previous 60 days.&#xD;
&#xD;
          4. Known history of poor compliance with medical treatments.&#xD;
&#xD;
          5. Patients currently enrolled in this study. Concurrent enrollment in the study is&#xD;
             prohibited.&#xD;
&#xD;
          6. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.&#xD;
&#xD;
          7. Patients currently receiving radiation therapy or chemotherapy.&#xD;
&#xD;
          8. Known or suspected local skin malignancy to the index diabetic ulcer.&#xD;
&#xD;
          9. Patients diagnosed with autoimmune connective tissue diseases.&#xD;
&#xD;
         10. Non-revascularizable surgical sites.&#xD;
&#xD;
         11. Active infection at index site or currently being treated with antibiotics&#xD;
&#xD;
         12. Any pathology that would limit the blood supply and compromise healing.&#xD;
&#xD;
         13. Patients that have received a biomedical or topical growth factor for their wound&#xD;
             within the previous 30 days. Study ulcer has been previously treated with tissue&#xD;
             engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g.&#xD;
             Oasis, Matristem) within the last 30 days.&#xD;
&#xD;
         14. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.&#xD;
&#xD;
         15. Known allergy to Gentamicin sulfate or Streptomycin sulfate.&#xD;
&#xD;
         16. Active Charcot deformity or major structural abnormalities of the foot.&#xD;
&#xD;
         17. Wounds that are greater than one year in duration without intermittent closure.&#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>William Tettelbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Research Associates, Inc.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockdale Podiatry Group</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research Inc</name>
      <address>
        <city>Castro Valley</city>
        <state>California</state>
        <zip>94546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Vascular Surgery Associates</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limb Preservation Platform</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novak Urgent Care and Family Practice</name>
      <address>
        <city>Indio</city>
        <state>California</state>
        <zip>92201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda VA Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92357</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>Palmtree Clinical Research, Inc.</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research, Inc.</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroWest Medical Center</name>
      <address>
        <city>Framingham</city>
        <state>Massachusetts</state>
        <zip>01702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jobst Vascular Institute, Promedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Research, Inc.</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorn VA</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futuro Clinical Trials, LLC</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMC Wound Care</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LDS Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Podiatry, Inc.</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</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>
  <!-- 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/NCT01693133
org study id: EFDFU003
nct id: NCT01693133
lead sponsor: 
has dmc: Yes
The objective of this study is to evaluate the percentage of patients with complete diabetic
      foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human
      amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects with complete closure of the study ulcer
time frame: Week 12
description: Assessed by the Investigator, during treatment (Visits 1 - 13).
measure: Time to complete closure for both groups
time frame: Up to 12 Weeks
description: As assessed by photographic evaluation and the Investigator
measure: Rate of wound closure
time frame: Up to Week 12
description: As assessed by photographic evaluation and the Investigator
measure: Incidence of ulcer recurrence
time frame: Up to Week 16
description: Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
measure: Quality of Life
time frame: Up to Week 12
description: Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.
measure: Cost effectiveness of treatment
time frame: Up to Week 12
description: Cost effectiveness of treatment regimen.
measure: Safety
time frame: Up to Week 16
description: The Safety population will be used for the analysis of safety endpoints.
arm group label: Control
arm group type: Other
description: Standard of Care: Moist Wound Therapy and Offloading
arm group label: EpiFix plus Standard of Care
arm group type: Experimental
description: Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)
intervention type: Other
intervention name: Standard of Care: Moist Wound Therapy and Offloading
description: Standard of Care: Moist Wound Therapy and Offloading
arm group label: Control
intervention type: Other
intervention name: EpiFix plus Standard of Care
description: Weekly application of EpiFix and Standard of Care
arm group label: EpiFix plus Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Tettelbach, MD
role: Principal Investigator
affiliation: Intermountain Medical Center
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country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer