<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/NCT02192242</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT02192242</nct_id>
  </id_info>
  <brief_title>Investigating a Model for Acute Ischemic Pain in Humans</brief_title>
  <official_title>Investigating a Model for Acute Ischemic Pain in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pathophysiology of acute ischemic pain is not well established. The aim of the present&#xD;
      study was to investigate acute ischemic pain in humans with a view to establish a scientific&#xD;
      model to perform future studies. The investigators examined whether peripheral nerve damage&#xD;
      and acute inflammation occur during short episodes of acute ischemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">August 2008</completion_date>
  <primary_completion_date type="Actual">August 2008</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Induce acute ischemic pain</measure>
    <time_frame>during treadmill exercise (less than 15 minutes)</time_frame>
    <description>To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Acute ischemic pain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>acute ischemic pain was induced by treadmill testing in all patients investigated</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acute ischemic pain</intervention_name>
    <description>acute ischemic pain was induced by treadmill exercise</description>
    <arm_group_label>Acute ischemic pain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 40 years&#xD;
&#xD;
          -  unilateral femoral-popliteal PAD, Fontaine grade II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with pain at rest or other pain origin&#xD;
&#xD;
          -  diabetic polyneuropathy&#xD;
&#xD;
          -  deep vein thrombosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip M Lang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Ludwig-Maximilians-University Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Munich, Pettenkoferstr. 8a</name>
      <address>
        <city>Munich</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Philip Lang</investigator_full_name>
    <investigator_title>Attending physician, Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>acute ischemic pain</keyword>
  <keyword>model</keyword>
  <keyword>S100</keyword>
  <keyword>interleukine 6</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT02192242
org study id: 001
nct id: NCT02192242
lead sponsor: 
has dmc: No
The pathophysiology of acute ischemic pain is not well established. The aim of the present
      study was to investigate acute ischemic pain in humans with a view to establish a scientific
      model to perform future studies. The investigators examined whether peripheral nerve damage
      and acute inflammation occur during short episodes of acute ischemia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Induce acute ischemic pain
time frame: during treadmill exercise (less than 15 minutes)
description: To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed.
arm group label: Acute ischemic pain
arm group type: Experimental
description: acute ischemic pain was induced by treadmill testing in all patients investigated
intervention type: Other
intervention name: acute ischemic pain
description: acute ischemic pain was induced by treadmill exercise
arm group label: Acute ischemic pain
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Philip M Lang, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology, Ludwig-Maximilians-University Munich
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Philip Lang
investigator title: Attending physician, Assistant Professor of Anesthesiology
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases