<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/NCT03027596</url>
  </required_header>
  <id_info>
    <org_study_id>639/2016</org_study_id>
    <nct_id>NCT03027596</nct_id>
  </id_info>
  <brief_title>Remote Ischemic Conditioning to Reduce Burn Wound Progression</brief_title>
  <acronym>RIC in burns</acronym>
  <official_title>Remote Ischemic Conditioning to Reduce Burn Wound Progression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BG Trauma Center Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BG Trauma Center Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burned skin areas, which were initially vital, can be irreversibly damaged by wound&#xD;
      progression. The aim of the present study is to evaluate the feasibility of ischemic&#xD;
      conditioning to reduce secondary wound progression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of burn depth</measure>
    <time_frame>day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180</time_frame>
    <description>Clinical assessment of burn depth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in skin's relative amount of hemoglobin</measure>
    <time_frame>day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180</time_frame>
    <description>relative amount of hemoglobin (Arbitrary Units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in skin's blood flow</measure>
    <time_frame>day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180</time_frame>
    <description>blood flow (Arbitrary Units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in skin's oxygen saturation</measure>
    <time_frame>day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180</time_frame>
    <description>oxygen saturation (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in skin elasticity</measure>
    <time_frame>day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360</time_frame>
    <description>objective measurement of the skin elasticity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in scare development between the study groups</measure>
    <time_frame>day 90, 180, 360</time_frame>
    <description>Assessment with the Vancouver scare scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Remote ischemic conditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Remote ischemic conditioning</intervention_name>
    <arm_group_label>Remote ischemic conditioning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand the study information and the consent to sign&#xD;
&#xD;
               -  Thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a&#xD;
                  (superficial partial)&#xD;
&#xD;
               -  At least one of the following sites must not have skin lesions&#xD;
&#xD;
                  : Upper arm right and left&#xD;
&#xD;
               -  hospital admission within 6 hours after trauma has taken place&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another experimental study&#xD;
&#xD;
               -  Pregnancy (women are subjected to a pregnancy test (urine)&#xD;
&#xD;
               -  Contraindication for the use of the tourniquet, for example Lymph drainage&#xD;
                  disorders after axillary lymphadenectomy or Irradiation of the axilla&#xD;
&#xD;
               -  Non-compliant patients who are, e.g. Intubated&#xD;
&#xD;
               -  Pure 3rd degree burns (full thickness) or charring&#xD;
&#xD;
               -  Thermal injuries older than 6 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Rothenberger, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jens Rothenberger, M.D.</last_name>
    <phone>+4970716063898</phone>
    <email>jens.rothenberger@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manuel Held, M.D., Priv.-Doz.</last_name>
    <phone>+4970716060</phone>
    <email>mheld@bgu-tuebingen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BG Trauma Center, University Tübingen, Germany</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Rothenberger, M.D.</last_name>
      <phone>+4970716063898</phone>
      <email>jens.rothenberger@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Manuel Held, M.D., Priv.-Doz.</last_name>
      <phone>+4970716060</phone>
      <email>mheld@bgu-tuebingen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>BG Trauma Center Tuebingen</investigator_affiliation>
    <investigator_full_name>Jens Rothenberger</investigator_full_name>
    <investigator_title>Dr.med</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03027596
org study id: 639/2016
nct id: NCT03027596
lead sponsor: 
has dmc: No
Burned skin areas, which were initially vital, can be irreversibly damaged by wound
      progression. The aim of the present study is to evaluate the feasibility of ischemic
      conditioning to reduce secondary wound progression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Change of burn depth
time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
description: Clinical assessment of burn depth
measure: Change in skin's relative amount of hemoglobin
time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
description: relative amount of hemoglobin (Arbitrary Units)
measure: Change in skin's blood flow
time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
description: blood flow (Arbitrary Units)
measure: Change in skin's oxygen saturation
time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
description: oxygen saturation (%)
measure: Change in skin elasticity
time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
description: objective measurement of the skin elasticity
measure: Differences in scare development between the study groups
time frame: day 90, 180, 360
description: Assessment with the Vancouver scare scale
arm group label: Remote ischemic conditioning
arm group type: Experimental
description: Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.
arm group label: Control group
arm group type: No Intervention
description: no intervention
intervention type: Procedure
intervention name: Remote ischemic conditioning
arm group label: Remote ischemic conditioning
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Rothenberger, M.D.
role: Principal Investigator
affiliation: Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
last name: Jens Rothenberger, M.D.
phone: +4970716063898
email: jens.rothenberger@gmail.com
last name: Manuel Held, M.D., Priv.-Doz.
phone: +4970716060
email: mheld@bgu-tuebingen.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: BG Trauma Center Tuebingen
investigator full name: Jens Rothenberger
investigator title: Dr.med
mesh term: Burns
sharing ipd: Undecided