<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/NCT03763331</url>
  </required_header>
  <id_info>
    <org_study_id>1801755556</org_study_id>
    <nct_id>NCT03763331</nct_id>
  </id_info>
  <brief_title>Home-based Leg Heat Therapy</brief_title>
  <acronym>HHT</acronym>
  <official_title>Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial 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>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the benefits of participating for 8 weeks in a&#xD;
      home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as&#xD;
      assessed by vascular function, walking tolerance and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      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 randomized, controlled&#xD;
      study is to evaluate the benefits of participating for 8 weeks in a home-based daily&#xD;
      treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by&#xD;
      vascular function, walking tolerance and quality of life. The central hypothesis of this&#xD;
      study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf&#xD;
      muscles during exercise and as a result, the onset of pain will be delayed and walking&#xD;
      performance will be enhanced. The duration (8 weeks) was chosen based on the recent report of&#xD;
      Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in&#xD;
      sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be&#xD;
      applied daily for 90 minutes using water-circulating 'pants' connected to a water pump.&#xD;
      Outcomes will be assessed at the halfway point (end of week 4), at the completion of the&#xD;
      intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">June 21, 2021</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>
    <intervention_model_description>Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants were informed that there were two different categories of heat therapy, &quot;low heat&quot; and &quot;high heat,&quot; and that both might be beneficial for claudication symptoms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 6-min Walk Distance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in 6-min walk distance from baseline to the 8-week follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Treadmill Peak Walking Time</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in treadmill peak walking time from baseline to 8-week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Calf Blood Flow</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leg Cutaneous Vascular Conductance</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in cutaneous vascular conductance from baseline to the 8-week follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Vascular Quality of Life Questionnaire-6 Score</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Short Form 36 Physical Functioning Score</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Sham treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heat Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control/Sham Treatment</intervention_name>
    <description>Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.</description>
    <arm_group_label>Sham treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heat Therapy</intervention_name>
    <description>Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.</description>
    <arm_group_label>Heat Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with a stable symptomatic PAD for ≥6 months&#xD;
&#xD;
          -  Ankle brachial index &lt;0.9 in at least one leg&#xD;
&#xD;
          -  Age between 40 and 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled Diabetes (HbA1C &gt; 8.5 measured within 3 months prior to date of consent)&#xD;
&#xD;
          -  Wheelchair bound&#xD;
&#xD;
          -  Use of a walking aid (i.e. cane, crutches, walker, motorized chair)&#xD;
&#xD;
          -  Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or&#xD;
             tissue loss&#xD;
&#xD;
          -  Impaired thermal sensation in the legs&#xD;
&#xD;
          -  Exercise-limiting comorbidity&#xD;
&#xD;
          -  Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is&#xD;
             present and symptoms have occurred; Stage D: presence of advanced heart disease with&#xD;
             continued heart failure symptoms requiring aggressive medical therapy)&#xD;
&#xD;
          -  Morbid obesity BMI &gt; 35 or unable to fit into water-circulating pants&#xD;
&#xD;
          -  Open wounds or ulcers on the extremity&#xD;
&#xD;
          -  Prior amputation&#xD;
&#xD;
          -  Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or&#xD;
             coronary revascularization in the previous three months&#xD;
&#xD;
          -  Planned revascularization or major surgery during the next six months&#xD;
&#xD;
          -  Plans to change medical therapy during the duration of the study&#xD;
&#xD;
          -  Active treatment for cancer&#xD;
&#xD;
          -  Chronic kidney disease (eGFR &lt;30 by MDRD or Mayo or Cockcroft-Gault formula).&#xD;
&#xD;
          -  HIV positive, active HBV or HCV disease.&#xD;
&#xD;
          -  Presence of any clinical condition that makes the patient not suitable to participate&#xD;
             in the trial.&#xD;
&#xD;
          -  Unable to walk on the treadmill&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R Motaganahalli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IU Heath Methodist</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 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>
  <results_first_submitted>August 7, 2022</results_first_submitted>
  <results_first_submitted_qc>February 27, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2023</results_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03763331/Prot_SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03763331/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited by referral from the peripheral vascular disease clinic at the Department of Vascular Surgery at Indiana University's Methodist Hospital, the Non-Invasive Vascular Laboratory at Methodist Hospital, and direct participant contact by the Indiana CTSI Research Network (ResNet) office.&#xD;
The first participant was randomized on January 14, 2019. Final follow-up occurred on June 21, 2021.</recruitment_details>
      <pre_assignment_details>A total of 542 patients were referred and screened for the study. Four hundred and twenty-eight participants were deemed ineligible and 80 refused to participate. The remaining 34 patients were randomly allocated to receive HT (n = 18) or the control treatment (n = 16).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sham</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Heat Therapy</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics of participants with PAD that completed the 8-wk intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>Sham</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Heat Therapy</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.9" spread="5.79"/>
                    <measurement group_id="B2" value="62.9" spread="8.9"/>
                    <measurement group_id="B3" value="65.9" spread="7.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in 6-min Walk Distance</title>
        <description>Change in 6-min walk distance from baseline to the 8-week follow-up</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 6-min Walk Distance</title>
          <description>Change in 6-min walk distance from baseline to the 8-week follow-up</description>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-5.8" upper_limit="14.3"/>
                    <measurement group_id="O2" value="21.3" lower_limit="10.1" upper_limit="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Treadmill Peak Walking Time</title>
        <description>Change in treadmill peak walking time from baseline to 8-week follow-up</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Treadmill Peak Walking Time</title>
          <description>Change in treadmill peak walking time from baseline to 8-week follow-up</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5" spread="111.2"/>
                    <measurement group_id="O2" value="109.5" spread="85.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Calf Blood Flow</title>
        <description>Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Calf Blood Flow</title>
          <description>Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up</description>
          <units>mL/min/100 g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" spread="21.9"/>
                    <measurement group_id="O2" value="-2.8" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Leg Cutaneous Vascular Conductance</title>
        <description>Change in cutaneous vascular conductance from baseline to the 8-week follow-up</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Leg Cutaneous Vascular Conductance</title>
          <description>Change in cutaneous vascular conductance from baseline to the 8-week follow-up</description>
          <units>percentage of maximal cutaneous vascular</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="13.9"/>
                    <measurement group_id="O2" value="-0.7" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Vascular Quality of Life Questionnaire-6 Score</title>
        <description>Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Vascular Quality of Life Questionnaire-6 Score</title>
          <description>Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.8"/>
                    <measurement group_id="O2" value="0.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Short Form 36 Physical Functioning Score</title>
        <description>Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sham</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Heat Therapy</title>
            <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Short Form 36 Physical Functioning Score</title>
          <description>Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="10.8"/>
                    <measurement group_id="O2" value="4.5" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the duration of the study (i.e. approximately 12 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sham</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Heat Therapy</title>
          <description>Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia at the onset of treadmill test</sub_title>
                <description>Supraventricular tachycardia at the onset of treadmill test</description>
                <counts group_id="E1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fall during the 6-min walk test</sub_title>
                <description>Fall during the 6-min walk test</description>
                <counts group_id="E1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Knee injury</sub_title>
                <description>Knee injury</description>
                <counts group_id="E1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Transient mild leg skin irritation</sub_title>
                <description>Transient mild leg skin irritation</description>
                <counts group_id="E1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Bruno Roseguini</name_or_title>
      <organization>Purdue University</organization>
      <phone>7654906284</phone>
      <email>brosegui@purdue.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03763331
org study id: 1801755556
nct id: NCT03763331
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to evaluate the benefits of participating for 8 weeks in a
      home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as
      assessed by vascular function, walking tolerance and quality of life.
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 randomized, controlled
      study is to evaluate the benefits of participating for 8 weeks in a home-based daily
      treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by
      vascular function, walking tolerance and quality of life. The central hypothesis of this
      study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf
      muscles during exercise and as a result, the onset of pain will be delayed and walking
      performance will be enhanced. The duration (8 weeks) was chosen based on the recent report of
      Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in
      sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be
      applied daily for 90 minutes using water-circulating 'pants' connected to a water pump.
      Outcomes will be assessed at the halfway point (end of week 4), at the completion of the
      intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants were informed that there were two different categories of heat therapy, "low heat" and "high heat," and that both might be beneficial for claudication symptoms.
measure: Change in 6-min Walk Distance
time frame: 8 weeks
description: Change in 6-min walk distance from baseline to the 8-week follow-up
measure: Change in Treadmill Peak Walking Time
time frame: 8 weeks
description: Change in treadmill peak walking time from baseline to 8-week follow-up
measure: Change in Peak Calf Blood Flow
time frame: 8 weeks
description: Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up
measure: Change in Leg Cutaneous Vascular Conductance
time frame: 8 weeks
description: Change in cutaneous vascular conductance from baseline to the 8-week follow-up
measure: Change in the Vascular Quality of Life Questionnaire-6 Score
time frame: 8 weeks
description: Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)
measure: Change in the Short Form 36 Physical Functioning Score
time frame: 8 weeks
description: Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.
arm group label: Sham treatment
arm group type: Sham Comparator
description: Participants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks..
arm group label: Heat Therapy
arm group type: Active Comparator
description: Participants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks.
intervention type: Device
intervention name: Control/Sham Treatment
description: Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
arm group label: Sham treatment
intervention type: Device
intervention name: Heat Therapy
description: Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.
arm group label: Heat Therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: R Motaganahalli
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
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
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 