<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/NCT02260609</url>
  </required_header>
  <id_info>
    <org_study_id>Osiris Protocol 310</org_study_id>
    <nct_id>NCT02260609</nct_id>
  </id_info>
  <brief_title>GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds</brief_title>
  <official_title>A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osiris Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Osiris Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, open-label, single-arm study to evaluate the safety and efficacy of&#xD;
      GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or&#xD;
      bone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>100% granulation of wound as determined by the investigator</measure>
    <time_frame>Up to 16 weeks after the Initial Treatment Visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to 100% granulation</measure>
    <time_frame>Up to 16 weeks after the Initial Treatment Visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of applications of Grafix®</measure>
    <time_frame>Up to 16 weeks after the Initial Treatment Visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of percent wound area reduction as determined by the investigator</measure>
    <time_frame>Up to 16 weeks after the Initial Treatment Visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closure of wound defined by 100% re-epithelialization</measure>
    <time_frame>Up to 16 weeks after the Initial Treatment Visit</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Complex Diabetic Foot Wounds</condition>
  <arm_group>
    <arm_group_label>Open-Label</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Grafix®: Cryopreserved Placental Membrane</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Grafix®</intervention_name>
    <description>The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.&#xD;
Patients will be treated for up to 16 weeks.&#xD;
Patients will be evaluated at screening and then weekly throughout the study or until wound closure.</description>
    <arm_group_label>Open-Label</arm_group_label>
    <other_name>Tissue</other_name>
    <other_name>Allograft Tissue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 18 years and 85 years of age inclusive, as of the date of screening&#xD;
&#xD;
          2. Confirmed diagnosis of Type I or Type II Diabetes&#xD;
&#xD;
          3. Index wound graded in the Texas Classification System as Grade II-III, Stage A or C&#xD;
             (without active infection)&#xD;
&#xD;
          4. Wound is located on the foot below the malleoli&#xD;
&#xD;
          5. Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely&#xD;
             cover the wound&#xD;
&#xD;
          6. Patient's wound extends through the dermis and into subcutaneous tissue with evidence&#xD;
             of exposed muscle, tendon, bone, and/or joint capsule&#xD;
&#xD;
          7. Patient has adequate circulation to the foot as documented by either:&#xD;
&#xD;
               -  Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or&#xD;
&#xD;
               -  In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 &gt; 30&#xD;
                  mmHg, or&#xD;
&#xD;
               -  Skin perfusion pressure &gt; 30 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Index Wound is of non-diabetic pathophysiology&#xD;
&#xD;
          2. Gangrene is present on any part of the affected foot&#xD;
&#xD;
          3. Index Wound is over a Charcot deformity&#xD;
&#xD;
          4. The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit&#xD;
&#xD;
          5. Patient has a glycated hemoglobin A1 (HbA1c) level of &gt;14%&#xD;
&#xD;
          6. Requiring intravenous (IV) antibiotics to treat the index wound infection at&#xD;
             enrollment&#xD;
&#xD;
          7. Patient has a wound within 15cm of the Index Ulcer identified for study consideration&#xD;
&#xD;
          8. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or&#xD;
             cytotoxic agents&#xD;
&#xD;
          9. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune&#xD;
             Deficiency Syndrome (AIDS)&#xD;
&#xD;
         10. Current evidence of osteomyelitis, cellulitis, or other evidence of infection&#xD;
             including fever or pus drainage from the wound site&#xD;
&#xD;
         11. Patient has active malignancy other than non-melanoma skin cancer&#xD;
&#xD;
         12. Patient's random blood sugar is &gt;450 mg/dl at screening&#xD;
&#xD;
         13. Patient has untreated alcohol or substance abuse at the time of screening, or is&#xD;
             deemed to be non-adherent to the protocol by the Investigator&#xD;
&#xD;
         14. Pregnant women&#xD;
&#xD;
         15. Patient is currently enrolled or participated in another investigational device, drug,&#xD;
             or biological trial within 30 days of screening&#xD;
&#xD;
         16. Patient has allergy to primary or secondary dressing materials used in this trial&#xD;
&#xD;
         17. Patient has had within the last 14 days, or is currently undergoing, or is planning&#xD;
             for wound treatments with enzymes, growth factors, living skin, dermal substitutes or&#xD;
             other advanced biological therapies&#xD;
&#xD;
         18. In the opinion of the Investigator, the patient is unsuitable for participation in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carl T. Hayden Medical Research Foundation</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Arizona VA Health Care System</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami VA</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Complex Wound</keyword>
  <keyword>Diabetic Foot Ulcer</keyword>
  <keyword>DFU</keyword>
  <keyword>GrafixCORE</keyword>
  <keyword>Exposed tendon</keyword>
  <keyword>Exposed bone</keyword>
  <keyword>Allograft tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02260609
org study id: Osiris Protocol 310
nct id: NCT02260609
lead sponsor: 
has dmc: No
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of
      GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or
      bone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 100% granulation of wound as determined by the investigator
time frame: Up to 16 weeks after the Initial Treatment Visit
measure: Time to 100% granulation
time frame: Up to 16 weeks after the Initial Treatment Visit
measure: Number of applications of Grafix®
time frame: Up to 16 weeks after the Initial Treatment Visit
measure: Measurement of percent wound area reduction as determined by the investigator
time frame: Up to 16 weeks after the Initial Treatment Visit
measure: Closure of wound defined by 100% re-epithelialization
time frame: Up to 16 weeks after the Initial Treatment Visit
arm group label: Open-Label
arm group type: Other
description: Grafix®: Cryopreserved Placental Membrane
intervention type: Other
intervention name: Grafix®
description: The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.
Patients will be treated for up to 16 weeks.
Patients will be evaluated at screening and then weekly throughout the study or until wound closure.
arm group label: Open-Label
other name: Tissue
other name: Allograft Tissue
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Wounds and Injuries