<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/NCT02209051</url>
  </required_header>
  <id_info>
    <org_study_id>DS2014.01.01</org_study_id>
    <nct_id>NCT02209051</nct_id>
  </id_info>
  <brief_title>Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers</brief_title>
  <official_title>A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management 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 primary goal of the study is to demonstrate the increased rate of complete wound closure&#xD;
      by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential study candidates will be Screened for Inclusion and Exclusion criteria after&#xD;
      providing informed consent. Candidates will have their wound cleansed and debrided (if&#xD;
      necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients&#xD;
      will return two weeks later for assessment.&#xD;
&#xD;
      Upon return, per the original protocol, patient would have been randomized at &lt;20% closure;&#xD;
      per Amendment 1, if the wound has closed &lt;30% in area during the 2 week Screening Period and&#xD;
      all other eligibility criteria are met, the patient will be randomized (1:1) to receive&#xD;
      either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.&#xD;
&#xD;
      All patients enrolled in this study will receive SOC. For the purposes of this study,&#xD;
      Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound&#xD;
      dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and&#xD;
      management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will&#xD;
      be applied after the wound has been debrided and hemostasis achieved. The wound will then be&#xD;
      dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive&#xD;
      dressing.&#xD;
&#xD;
      The patient will return once weekly for wound care, photographs and ulcer measurement. At&#xD;
      each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon&#xD;
      physician judgment. All patients complete their participation at Week 6.&#xD;
&#xD;
      This is an open label study and no attempt will be made to blind subjects or Investigators to&#xD;
      randomization allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to complete wound closure of the target ulcer</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of wound closure</measure>
    <time_frame>8 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence, severity and type of adverse events</measure>
    <time_frame>8 Weeks</time_frame>
    <description>This outcome measure represents a composite of collected adverse event data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life assessment</measure>
    <time_frame>8 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Diabetic Foot Ulcers</condition>
  <arm_group>
    <arm_group_label>AMNIOEXCEL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human Amniotic Membrane Allograft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care, Diabetic Foot Ulcers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Advanced wound care dressings and offloading of wound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AMNIOEXCEL</intervention_name>
    <description>Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.</description>
    <arm_group_label>AMNIOEXCEL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care, Diabetic Foot Ulcers</intervention_name>
    <description>Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure</description>
    <arm_group_label>AMNIOEXCEL</arm_group_label>
    <arm_group_label>Standard of Care, Diabetic Foot Ulcers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. an ambulatory person at least 18 years of age at the time of informed consent.&#xD;
&#xD;
          2. type 1 or type 2 diabetes mellitus.&#xD;
&#xD;
          3. glycosylated hemoglobin (HbA1c) of ≤12%&#xD;
&#xD;
          4. at least one wound that is/has:&#xD;
&#xD;
               -  Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),&#xD;
&#xD;
               -  duration of at least 1 month,&#xD;
&#xD;
               -  no clinical signs of infection or osteomyelitis,&#xD;
&#xD;
               -  between 1cm2 and 25cm2 in area,&#xD;
&#xD;
               -  per original protocol, closed &lt;20% in area during the Screening Period; per&#xD;
                  Amendment #1, closed &lt;30% in area during Screening and&#xD;
&#xD;
               -  located on the foot, distal to malleoli.&#xD;
&#xD;
          5. adequate circulation to the affected extremity&#xD;
&#xD;
          6. serum creatinine of &lt;3.0mg/dl.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. participated in another clinical trial within 30 days prior to consent,&#xD;
&#xD;
          2. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and&#xD;
             actively remodeling)&#xD;
&#xD;
          3. receiving radiation or chemotherapy of any kind,&#xD;
&#xD;
          4. known or suspected malignancy of current ulcer,&#xD;
&#xD;
          5. pregnant or breast feeding,&#xD;
&#xD;
          6. an active malignant disease,&#xD;
&#xD;
          7. receiving hemo- or peritoneal dialysis,&#xD;
&#xD;
          8. sickle cell anemia or Raynaud's syndrome,&#xD;
&#xD;
          9. diagnosis of autoimmune connective tissue disease,&#xD;
&#xD;
         10. received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days&#xD;
             prior to consent,&#xD;
&#xD;
         11. exposed bone, tendon or joint capsule in the study ulcer,&#xD;
&#xD;
         12. currently receiving antibiotics (for any reason), or&#xD;
&#xD;
         13. taking medications considered to be immune system modulators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Associated Foot and Ankle Specialists, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85015</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>Pacific Wound Center</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Coast Cardiovascular Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barry University Clinical Research</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Hospital - Plymouth</name>
      <address>
        <city>Plymouth</city>
        <state>Massachusetts</state>
        <zip>02360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne Memorial Hospital</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27533</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>November 30, 2017</last_update_submitted>
  <last_update_submitted_qc>November 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot Ulcers</keyword>
  <keyword>AMNIOEXCEL</keyword>
  <keyword>Wagner Grade 1 or 2 foot ulcers</keyword>
  <keyword>Wound</keyword>
  <keyword>Foot health</keyword>
  <keyword>Ulcer</keyword>
  <keyword>Foot Ulcer</keyword>
  <keyword>Diabetic Foot</keyword>
  <keyword>Foot Diseases</keyword>
  <keyword>Skin Diseases</keyword>
  <keyword>Leg Ulcer</keyword>
  <keyword>Skin Ulcer</keyword>
  <keyword>Diabetic Angiopathies</keyword>
  <keyword>Vascular Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Diabetes Complications</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Endocrine System Diseases</keyword>
  <keyword>Diabetic Neuropathies</keyword>
  <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/NCT02209051
org study id: DS2014.01.01
nct id: NCT02209051
lead sponsor: 
has dmc: No
The primary goal of the study is to demonstrate the increased rate of complete wound closure
      by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
Potential study candidates will be Screened for Inclusion and Exclusion criteria after
      providing informed consent. Candidates will have their wound cleansed and debrided (if
      necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients
      will return two weeks later for assessment.

      Upon return, per the original protocol, patient would have been randomized at <20% closure;
      per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and
      all other eligibility criteria are met, the patient will be randomized (1:1) to receive
      either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.

      All patients enrolled in this study will receive SOC. For the purposes of this study,
      Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound
      dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and
      management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will
      be applied after the wound has been debrided and hemostasis achieved. The wound will then be
      dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive
      dressing.

      The patient will return once weekly for wound care, photographs and ulcer measurement. At
      each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon
      physician judgment. All patients complete their participation at Week 6.

      This is an open label study and no attempt will be made to blind subjects or Investigators to
      randomization allocation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
time frame: 8 weeks
measure: Time to complete wound closure of the target ulcer
time frame: 8 weeks
measure: Rate of wound closure
time frame: 8 Weeks
measure: Incidence, severity and type of adverse events
time frame: 8 Weeks
description: This outcome measure represents a composite of collected adverse event data.
measure: Changes in Quality of Life assessment
time frame: 8 Weeks
arm group label: AMNIOEXCEL
arm group type: Active Comparator
description: Human Amniotic Membrane Allograft
arm group label: Standard of Care, Diabetic Foot Ulcers
arm group type: Active Comparator
description: Advanced wound care dressings and offloading of wound.
intervention type: Other
intervention name: AMNIOEXCEL
description: Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
arm group label: AMNIOEXCEL
intervention type: Other
intervention name: Standard of Care, Diabetic Foot Ulcers
description: Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
arm group label: AMNIOEXCEL
arm group label: Standard of Care, Diabetic Foot Ulcers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer