<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/NCT02248077</url>
  </required_header>
  <id_info>
    <org_study_id>CM-567</org_study_id>
    <nct_id>NCT02248077</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers</brief_title>
  <official_title>A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytomedix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytomedix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to demonstrate the outcome of complete ulcer closure of patients with&#xD;
      Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary&#xD;
      Care (UCC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was redesigned in collaboration with CMS before it started.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 4</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>Complete Ulcer Closure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of patients with complete ulcer closure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Impaired Wound Healing</condition>
  <arm_group>
    <arm_group_label>AutoloGel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AutoloGel consists of platelet-rich plasma (PRP) gel produced from the patient's own peripheral blood and pharmaceutical additives including calcium chloride, thrombin and ascorbic acid. The AutoloGel product is obtained by processing the patient's own blood using the AutoloGel System. After the final AutoloGel formulation is produced it is used immediately for patient's specific ulcer care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual and Customary Care (UCC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AutoloGel</intervention_name>
    <arm_group_label>AutoloGel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual and Customary Care (UCC)</intervention_name>
    <arm_group_label>Usual and Customary Care (UCC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For DFU indication:&#xD;
&#xD;
          1. Medicare beneficiary&#xD;
&#xD;
          2. Males or females ≥ 18 years of age&#xD;
&#xD;
          3. Type I or II diabetes requiring medical treatment as determined by the physician&#xD;
&#xD;
          4. The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see&#xD;
             Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal,&#xD;
             plantar, medial, or lateral aspect of the foot (including all toe surfaces and the&#xD;
             heel)&#xD;
&#xD;
          5. Patients have been treated with UCC at the center for 2 weeks prior to randomization&#xD;
             with no greater than 20% reduction in wound area or volume and documented wound&#xD;
             measurements are available&#xD;
&#xD;
          6. For patients with multiple potential Index DFUs, the largest ulcer will be selected.&#xD;
             There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers&#xD;
             are closer than 4 cm, the patient should not be enrolled (screen failure)&#xD;
&#xD;
          7. Demonstrated offloading regimen&#xD;
&#xD;
          8. A wound age of ≥ 30 days at the Screening Visit&#xD;
&#xD;
          9. Patient must be willing to comply with the protocol, which will be assessed by&#xD;
             enrolling clinician.&#xD;
&#xD;
         10. Patient must sign an Informed Consent Form prior to any study-related procedures.&#xD;
&#xD;
        For VLU indication:&#xD;
&#xD;
          1. Medicare beneficiary&#xD;
&#xD;
          2. Males or females ≥ 18 years of age&#xD;
&#xD;
          3. Diagnosed venous disease&#xD;
&#xD;
          4. Patients have been seen at the center/site for 2 weeks prior to randomization with no&#xD;
             greater than 20% reduction in wound area or volume and documented wound measurements&#xD;
             are available&#xD;
&#xD;
          5. The non-healing wound is located between the knee and ankle and may include ankle&#xD;
&#xD;
          6. For patients with multiple potential Index VLUs, the largest ulcer will be selected.&#xD;
             There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers&#xD;
             are closer than 4 cm, the patient should not be enrolled (screen failure)&#xD;
&#xD;
          7. Demonstrated compression regimen&#xD;
&#xD;
          8. A wound age of ≥ 30 days at the Screening visit&#xD;
&#xD;
          9. Patient must be willing to comply with the protocol, which will be assessed by&#xD;
             enrolling clinician&#xD;
&#xD;
         10. Patient must sign an Informed Consent prior to any study-related procedures.&#xD;
&#xD;
        For PU indication:&#xD;
&#xD;
          1. Medicare beneficiary&#xD;
&#xD;
          2. Males or females ≥ 18 years of age&#xD;
&#xD;
          3. Ulcer of pressure/shear etiology (Stage II, III, IV, see Section 17.13 Appendix 13 for&#xD;
             stage definitions)&#xD;
&#xD;
          4. Patients have been seen at the site for 2 weeks prior to randomization with no greater&#xD;
             than 20% reduction in wound area or volume and documented wound measurements are&#xD;
             available&#xD;
&#xD;
          5. The single wound to be applied Study Treatment (Index Ulcer) that is located on the&#xD;
             heel, ischium, sacrum, coccyx or trochanter&#xD;
&#xD;
          6. For patients with multiple potential PUs, the largest ulcer will be selected. There&#xD;
             must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are&#xD;
             closer than 4 cm, the patient should not be enrolled (screen failure)&#xD;
&#xD;
          7. Demonstrated pressure relief regimen&#xD;
&#xD;
          8. A wound age of ≥ 30 days at Screening visit&#xD;
&#xD;
          9. Patient must be willing to comply with the Protocol, which will be assessed by&#xD;
             enrolling clinician.&#xD;
&#xD;
         10. Patient must sign an Informed Consent prior to any study-related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients known to be sensitive to AutoloGel components (calcium chloride, thrombin,&#xD;
             ascorbic acid) and/or materials of bovine origin&#xD;
&#xD;
          2. Presence of another wound that is concurrently treated and might interfere with the&#xD;
             treatment of the Index wound&#xD;
&#xD;
          3. Malignancy in wound bed&#xD;
&#xD;
          4. Active clinical wound infection.&#xD;
&#xD;
          5. Patient has inadequate venous access for repeated blood draw required for AutoloGel&#xD;
             processing&#xD;
&#xD;
          6. Patients who are cognitively impaired and do not have a healthcare proxy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://cytomedix.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 19, 2016</last_update_submitted>
  <last_update_submitted_qc>October 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 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>Varicose Ulcer</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Pressure 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/NCT02248077
org study id: CM-567
nct id: NCT02248077
lead sponsor: 
has dmc: No
This study is designed to demonstrate the outcome of complete ulcer closure of patients with
      Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary
      Care (UCC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Ulcer Closure
time frame: 12 weeks
description: Proportion of patients with complete ulcer closure
arm group label: AutoloGel
arm group type: Active Comparator
description: AutoloGel consists of platelet-rich plasma (PRP) gel produced from the patient's own peripheral blood and pharmaceutical additives including calcium chloride, thrombin and ascorbic acid. The AutoloGel product is obtained by processing the patient's own blood using the AutoloGel System. After the final AutoloGel formulation is produced it is used immediately for patient's specific ulcer care.
arm group label: Usual and Customary Care (UCC)
arm group type: Other
description: Standard of care
intervention type: Device
intervention name: AutoloGel
arm group label: AutoloGel
intervention type: Other
intervention name: Usual and Customary Care (UCC)
arm group label: Usual and Customary Care (UCC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://cytomedix.com
description: Related Info
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Varicose Ulcer
mesh term: Foot Ulcer
mesh term: Leg Ulcer
mesh term: Pressure Ulcer