<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/NCT03763357</url>
  </required_header>
  <id_info>
    <org_study_id>1809400414</org_study_id>
    <nct_id>NCT03763357</nct_id>
  </id_info>
  <brief_title>Acute Effects of Leg Heating on Skeletal Muscle Blood Flow</brief_title>
  <official_title>Acute Effects of Leg Heating on Skeletal Muscle Blood Flow in Patients With Symptomatic Peripheral Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roseguini, Bruno, PhD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</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>
      The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients&#xD;
      with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer&#xD;
      to study direct measurement of blood flow in the legs pre and post heat treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cilostazol is the only effective medication available to treat walking pain (intermittent&#xD;
      claudication) and it has multiple side effects. Overall improvement in walking performance in&#xD;
      patients who use cilostazol is small. Endovascular and surgical interventions are effective&#xD;
      alternatives for patients who don't respond to medical therapy, however, these procedures are&#xD;
      costly and only applicable to patients with certain lesions types and carry a high risk of&#xD;
      restenosis.&#xD;
&#xD;
      Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance&#xD;
      vascular function of the leg in old individuals. The objective of this study is to test the&#xD;
      hypothesis that a single session of heat therapy will increase local muscle tissue blood flow&#xD;
      in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.&#xD;
&#xD;
      Subjects who have met inclusion criteria will volunteer for a single experimental visit.&#xD;
      Participants will wear the water circulating pants and asked to rest supine for 30 minutes&#xD;
      inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes&#xD;
      with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of&#xD;
      62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute&#xD;
      baseline period, after 45 minutes of heat therapy and at the end of the intervention (90&#xD;
      minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations&#xD;
      will not interfere with acquisition of a subsequent PET scan at this timing interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to obtain CT contrast from provider&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2022</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>
    <intervention_model_description>All of the subjects in this study will receive leg heat therapy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in calf blood flow</measure>
    <time_frame>Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen</time_frame>
    <description>Calf muscle perfusion rate (mL⋅min-1⋅g-1) will be obtained after administration of tracer 62Cu-ETS before, during and after exposure to heat therapy or a control intervention. Changes from in perfusion rate from baseline to 45 minutes and 90 minutes of heating or control will be measured.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Heat Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject will dress in water-circulating trousers that are connected to a Heat Therapy (HT) pump. Warm water (42-43 degrees C) will be perfused through the pants for 90 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heat Therapy (HT)</intervention_name>
    <description>Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS.</description>
    <arm_group_label>Heat Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with a stable symptomatic claudication for &gt;/= 6 months&#xD;
&#xD;
          -  Ankle brachial index &lt; 0.9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  Critical limb ischemia&#xD;
&#xD;
          -  Prior amputation&#xD;
&#xD;
          -  Exercise-limiting co-morbidity&#xD;
&#xD;
          -  Recent (&lt; 3 months) intra-inguinal revascularization or planned in study period&#xD;
&#xD;
          -  Plans to change medical therapy during duration of study&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Chronic kidney disease (eGFR &lt; 30)&#xD;
&#xD;
          -  HIV positive, active HBV or HCV disease&#xD;
&#xD;
          -  Presence of an clinical condition that makes the patient not suitable to participate&#xD;
             in the trial&#xD;
&#xD;
          -  Peripheral neuropathy, numbness or paresthesia in the legs&#xD;
&#xD;
          -  Morbid obesity BMI &gt; 36 or unable to fit into water-circulating pants&#xD;
&#xD;
          -  Open wounds or ulcers on the extremity&#xD;
&#xD;
          -  Claustrophobia/unable to tolerate PET/CT scanning&#xD;
&#xD;
          -  Women of child-bearing age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raghu L Motaanahalli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Raghu Motaganahalli</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>
  <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/NCT03763357
org study id: 1809400414
nct id: NCT03763357
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients
      with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer
      to study direct measurement of blood flow in the legs pre and post heat treatment.
Cilostazol is the only effective medication available to treat walking pain (intermittent
      claudication) and it has multiple side effects. Overall improvement in walking performance in
      patients who use cilostazol is small. Endovascular and surgical interventions are effective
      alternatives for patients who don't respond to medical therapy, however, these procedures are
      costly and only applicable to patients with certain lesions types and carry a high risk of
      restenosis.

      Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance
      vascular function of the leg in old individuals. The objective of this study is to test the
      hypothesis that a single session of heat therapy will increase local muscle tissue blood flow
      in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.

      Subjects who have met inclusion criteria will volunteer for a single experimental visit.
      Participants will wear the water circulating pants and asked to rest supine for 30 minutes
      inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes
      with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of
      62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute
      baseline period, after 45 minutes of heat therapy and at the end of the intervention (90
      minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations
      will not interfere with acquisition of a subsequent PET scan at this timing interval.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All of the subjects in this study will receive leg heat therapy.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in calf blood flow
time frame: Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen
description: Calf muscle perfusion rate (mL⋅min-1⋅g-1) will be obtained after administration of tracer 62Cu-ETS before, during and after exposure to heat therapy or a control intervention. Changes from in perfusion rate from baseline to 45 minutes and 90 minutes of heating or control will be measured.
arm group label: Heat Therapy
arm group type: Experimental
description: Subject will dress in water-circulating trousers that are connected to a Heat Therapy (HT) pump. Warm water (42-43 degrees C) will be perfused through the pants for 90 minutes.
intervention type: Device
intervention name: Heat Therapy (HT)
description: Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS.
arm group label: Heat Therapy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Raghu L Motaanahalli, MD
role: Principal Investigator
affiliation: Indiana University
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Raghu Motaganahalli
investigator title: Associate Professor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No