<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/NCT03796988</url>
  </required_header>
  <id_info>
    <org_study_id>20180154</org_study_id>
    <nct_id>NCT03796988</nct_id>
  </id_info>
  <brief_title>Autologous Regeneration of Tissue (ART) for Wound Healing</brief_title>
  <official_title>Autologous Regeneration of Tissue (ART) for Wound Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medline Industries</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn about a new device, Autologous Regeneration of&#xD;
      Tissue (ART), for collecting skin grafts from participant's own skin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</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>Change of pain on harvesting of skin at donor site.</measure>
    <time_frame>Baseline, Day 56</time_frame>
    <description>Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to healing of donor sites</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>At each weekly visit, the donor site will be assessed for wound area in cm^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing of recipient site</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>At each weekly visit, the recipient area will be assessed for healing area percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histologic evaluation</measure>
    <time_frame>Up to Day 56</time_frame>
    <description>As measured by tissue samples from biopsy</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Wound of Skin</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Autologous Regeneration of Tissue (ART) device</intervention_name>
    <description>This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults from 18 to 90 years of age.&#xD;
&#xD;
          -  Patients that have a chronic wound in any area of the body defined as having been&#xD;
             present for at least 30 days of duration.&#xD;
&#xD;
          -  Able and willing to give consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women (Urine hCG test will be performed at baseline on women of child bearing&#xD;
             potential).&#xD;
&#xD;
          -  Adults unable to consent.&#xD;
&#xD;
          -  Prisoners.&#xD;
&#xD;
          -  Subjects requiring concurrent systemic antimicrobials during the study period for any&#xD;
             infection.&#xD;
&#xD;
          -  Subjects with leg lesions and clinically significant and unreconstructed peripheral&#xD;
             arterial disease.&#xD;
&#xD;
          -  Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic&#xD;
             agents.&#xD;
&#xD;
          -  Subjects who require treatment for a primary or metastatic malignancy (other than&#xD;
             squamous or basal cell carcinoma of the skin).&#xD;
&#xD;
          -  Subjects with other conditions considered by the investigator to be reasons for&#xD;
             disqualification that may jeopardize subject safety or interfere with the objectives&#xD;
             of the trial (e.g., acute illness or exacerbation of chronic illness, lack of&#xD;
             motivation, history of poor compliance).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hadar Lev-Tov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Hadar Lev-Tov</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03796988
org study id: 20180154
nct id: NCT03796988
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research study is to learn about a new device, Autologous Regeneration of
      Tissue (ART), for collecting skin grafts from participant's own skin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of pain on harvesting of skin at donor site.
time frame: Baseline, Day 56
description: Pain assessed using a Pain Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (worst possible pain)
measure: Time to healing of donor sites
time frame: Up to Day 56
description: At each weekly visit, the donor site will be assessed for wound area in cm^2
measure: Wound healing of recipient site
time frame: Up to Day 56
description: At each weekly visit, the recipient area will be assessed for healing area percentage
measure: Histologic evaluation
time frame: Up to Day 56
description: As measured by tissue samples from biopsy
arm group label: Intervention arm
arm group type: Experimental
description: The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.
intervention type: Device
intervention name: Autologous Regeneration of Tissue (ART) device
description: This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hadar Lev-Tov, MD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Hadar Lev-Tov
investigator title: Assistant Professor
mesh term: Wounds and Injuries
sharing ipd: No