xml: <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/NCT05991765</url>
    </required_header>
    <id_info>
      <org_study_id>DigitTip2023</org_study_id>
      <nct_id>NCT05991765</nct_id>
    </id_info>
    <brief_title>Evaluation of Digit Tip and Split Skin Donor Site Transcriptome</brief_title>
    <official_title>Evaluation of Digit Tip and Split Skin Donor Site Transcriptome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Schleswig-Holstein</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Schleswig-Holstein</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Regrowth of amputated fingertips presents a unique regenerative healing process in mammals,&#xD;
        with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar&#xD;
        formation. In addition, wound healing from split-thickness donor sites shows almost scar-free&#xD;
        healing. Transcriptome analysis is necessary to better understand the specific healing&#xD;
        mechanisms of these two wound entities. Since no data are available to date, this study aims&#xD;
        to fill the gap.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Regrowth of amputated fingertips presents a unique regenerative healing process in mammals,&#xD;
        with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar&#xD;
        formation. In addition, wound healing from split-thickness donor sites shows almost scar-free&#xD;
        healing. Transcriptome analysis is necessary to better understand the specific healing&#xD;
        mechanisms of these two wound entities. Since no data are available to date, this study aims&#xD;
        to fill the gap.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in RNA-Expression pattern</measure>
      <time_frame>5 Weeks</time_frame>
      <description>Differences in RNA-Expression pattern between Digit Tip Wound and Split Skin Donor Site Wound</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">75</enrollment>
    <condition>Digit Tip Wound</condition>
    <condition>Split Skin Donor Site</condition>
    <arm_group>
      <arm_group_label>Digit Tip Wound</arm_group_label>
      <description>Experimental Wound Exudate from Digit Tip Wounds</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Split Skin Donor Site Wound</arm_group_label>
      <description>Active Comparator Wound Exudate from Split Skin Donor Site Wound</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Digit Tip Wound</intervention_name>
      <description>Digit Tip Wound Exudate Sample Collected while Dressing Change</description>
      <arm_group_label>Digit Tip Wound</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Split Skin Donor Site Wound</intervention_name>
      <description>Split Skin Donor Site Wound Exudate Sample while Dressing Change</description>
      <arm_group_label>Split Skin Donor Site Wound</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Consent-capable patients ≥18 years of age with either Digit Tip Wound or Split Skin Donor&#xD;
          Site&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Digit Tip Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18&#xD;
               years of age with clean Digit Tip Wound&#xD;
  &#xD;
            2. Split Skin Donor Site Wound: Wound Exudate from healthy patients: Consent-capable&#xD;
               patients ≥18 years of age with clean Split Skin Donor Site Wound&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inflammation&#xD;
  &#xD;
            -  Borderline&#xD;
  &#xD;
            -  Infectious Disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>University of Schleswig-Holstein</name>
        <address>
          <city>Lübeck</city>
          <state>Schleswig-Holstein</state>
          <zip>23538</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
      <investigator_full_name>Tobias Kisch</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Digit Tip</keyword>
    <keyword>Split Skin Donor Site</keyword>
    <keyword>Transcriptome</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991765
  org study id: DigitTip2023
  nct id: NCT05991765
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Regrowth of amputated fingertips presents a unique regenerative healing process in mammals,
        with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar
        formation. In addition, wound healing from split-thickness donor sites shows almost scar-free
        healing. Transcriptome analysis is necessary to better understand the specific healing
        mechanisms of these two wound entities. Since no data are available to date, this study aims
        to fill the gap.
  Regrowth of amputated fingertips presents a unique regenerative healing process in mammals,
        with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar
        formation. In addition, wound healing from split-thickness donor sites shows almost scar-free
        healing. Transcriptome analysis is necessary to better understand the specific healing
        mechanisms of these two wound entities. Since no data are available to date, this study aims
        to fill the gap.
  observational model: Other
  time perspective: Prospective
  measure: Differences in RNA-Expression pattern
  time frame: 5 Weeks
  description: Differences in RNA-Expression pattern between Digit Tip Wound and Split Skin Donor Site Wound
  arm group label: Digit Tip Wound
  description: Experimental Wound Exudate from Digit Tip Wounds
  arm group label: Split Skin Donor Site Wound
  description: Active Comparator Wound Exudate from Split Skin Donor Site Wound
  intervention type: Other
  intervention name: Digit Tip Wound
  description: Digit Tip Wound Exudate Sample Collected while Dressing Change
  arm group label: Digit Tip Wound
  intervention type: Other
  intervention name: Split Skin Donor Site Wound
  description: Split Skin Donor Site Wound Exudate Sample while Dressing Change
  arm group label: Split Skin Donor Site Wound
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital Schleswig-Holstein
  investigator full name: Tobias Kisch
  investigator title: Principal Investigator