<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/NCT03001531</url>
  </required_header>
  <id_info>
    <org_study_id>2014-05</org_study_id>
    <nct_id>NCT03001531</nct_id>
  </id_info>
  <brief_title>Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia</brief_title>
  <acronym>DecuHeat</acronym>
  <official_title>Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preconditioning of regional skin is known to reduce post surgery complications due to&#xD;
      increased perfusion and better skin condition. The aim of this study is to prove that local&#xD;
      heating through a standardized device in patients with spinal cord injury induces no burnings&#xD;
      or other relevant side effects. The investigators expect an increased regional perfusion,&#xD;
      temperature and redness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>presence of burn injury</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood perfusion</measure>
    <time_frame>before and 1min after the application of light or heat</time_frame>
    <description>perfusion (PeriFlux System 5000) in perfusion units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin surface temperature</measure>
    <time_frame>before and 1min after the application of light or heat</time_frame>
    <description>measuring surface temperature with thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin redness</measure>
    <time_frame>before and 1min after the application of light or heat</time_frame>
    <description>visual inspection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Perfusion; Complications</condition>
  <arm_group>
    <arm_group_label>HydroSun</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>application of ultraviolet light for 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hilotherm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>application of heat (maximum of 43°C) for 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HydroSun</intervention_name>
    <description>a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp</description>
    <arm_group_label>HydroSun</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hilotherm</intervention_name>
    <description>a skin area of the lower limb will be treated three times with heat applied by a sleeve</description>
    <arm_group_label>Hilotherm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women&#xD;
&#xD;
          -  aged from 18 to 65 years&#xD;
&#xD;
          -  paraplegia Th2-Th12&#xD;
&#xD;
          -  spinal cord injury had occurred &gt;12 weeks ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infections&#xD;
&#xD;
          -  fever&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  heart failure stadium III&#xD;
&#xD;
          -  renal insufficiency stadium III.&#xD;
&#xD;
          -  scars, wounds or other injuries in the area of treatment&#xD;
&#xD;
          -  skin type V and VI on Fitzpatrick scale&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre</name>
      <address>
        <city>Nottwil</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>November 10, 2020</last_update_submitted>
  <last_update_submitted_qc>November 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Complete paraplegia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paraplegia</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/NCT03001531
org study id: 2014-05
nct id: NCT03001531
lead sponsor: 
collaborator: 
has dmc: No
Preconditioning of regional skin is known to reduce post surgery complications due to
      increased perfusion and better skin condition. The aim of this study is to prove that local
      heating through a standardized device in patients with spinal cord injury induces no burnings
      or other relevant side effects. The investigators expect an increased regional perfusion,
      temperature and redness.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: presence of burn injury
time frame: up to 24 hours
description: grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
measure: blood perfusion
time frame: before and 1min after the application of light or heat
description: perfusion (PeriFlux System 5000) in perfusion units
measure: skin surface temperature
time frame: before and 1min after the application of light or heat
description: measuring surface temperature with thermometer
measure: skin redness
time frame: before and 1min after the application of light or heat
description: visual inspection
arm group label: HydroSun
arm group type: Active Comparator
description: application of ultraviolet light for 30 minutes
arm group label: Hilotherm
arm group type: Active Comparator
description: application of heat (maximum of 43°C) for 30 minutes
intervention type: Device
intervention name: HydroSun
description: a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
arm group label: HydroSun
intervention type: Device
intervention name: Hilotherm
description: a skin area of the lower limb will be treated three times with heat applied by a sleeve
arm group label: Hilotherm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Paraplegia
sharing ipd: No