<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/NCT03266861</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A00912-51</org_study_id>
    <nct_id>NCT03266861</nct_id>
  </id_info>
  <brief_title>Lactate Increase in Peripheral Artery Disease</brief_title>
  <acronym>STELLA</acronym>
  <official_title>Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the&#xD;
      only continuous method that estimates the importance of ischemia, bilaterally and segment of&#xD;
      limb by segment of limb. The determination of the lactates concentration, with micro method&#xD;
      from earlobe sampling, is very widely validated in physiology and exercise physiopathology;&#xD;
      and it is widely used, by laboratories, for exercise investigation in athletes. We use it in&#xD;
      routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.&#xD;
&#xD;
      The present study hypothesises a significant relationship between lactatemia variation&#xD;
      (difference between lactatemia after 3 minutes of recovery from walking and the value at&#xD;
      rest) and tcpO2 &quot;decrease from rest of oxygen pressure (DROP) values for patients with&#xD;
      peripheral artery disease (PAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lactates sample (100 microliter) will be collected at rest Ankle brachial index is measured&#xD;
      at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and&#xD;
      results will be expressed as the minimal value of the DROP index (Limb changes minus chest&#xD;
      changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Lactates&#xD;
      sample (100 microliter) will be collected at minute 3 of recovery from walking Correlation of&#xD;
      lactate increase to the sum of DROP values wil be studied&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">October 10, 2020</completion_date>
  <primary_completion_date type="Actual">October 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of lactate results to oximetry</measure>
    <time_frame>one and a half hour</time_frame>
    <description>Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of lactate results to resting Ankle to brachial index (ABI)</measure>
    <time_frame>one and a half hour</time_frame>
    <description>Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>Claudication, Intermittent</condition>
  <arm_group>
    <arm_group_label>Patients undergoing exercise oximetry</arm_group_label>
    <description>Patients with PAD referred for treadmill testing and exercise oximetry</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Exercise oximetry</intervention_name>
    <description>Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period</description>
    <arm_group_label>Patients undergoing exercise oximetry</arm_group_label>
    <other_name>Capillary blood sampling from the earlobe</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with peripheral artery disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patient able to walk on a treadmill&#xD;
&#xD;
          -  Patient covered by the French health insurance&#xD;
&#xD;
          -  Patient able to understand the protocol&#xD;
&#xD;
          -  Patient agrees to be involve in the protocol and sign the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refuses to participate at the this protocol&#xD;
&#xD;
          -  Patient has a wash-out period for another clinical trial&#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>Pierre ABRAHAM, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitaml in Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalier universitaire</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 9, 2021</last_update_submitted>
  <last_update_submitted_qc>July 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Intermittent Claudication</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/NCT03266861
org study id: 2017-A00912-51
nct id: NCT03266861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the
      only continuous method that estimates the importance of ischemia, bilaterally and segment of
      limb by segment of limb. The determination of the lactates concentration, with micro method
      from earlobe sampling, is very widely validated in physiology and exercise physiopathology;
      and it is widely used, by laboratories, for exercise investigation in athletes. We use it in
      routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.

      The present study hypothesises a significant relationship between lactatemia variation
      (difference between lactatemia after 3 minutes of recovery from walking and the value at
      rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with
      peripheral artery disease (PAD).
Lactates sample (100 microliter) will be collected at rest Ankle brachial index is measured
      at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and
      results will be expressed as the minimal value of the DROP index (Limb changes minus chest
      changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Lactates
      sample (100 microliter) will be collected at minute 3 of recovery from walking Correlation of
      lactate increase to the sum of DROP values wil be studied
observational model: Cohort
time perspective: Prospective
measure: Correlation of lactate results to oximetry
time frame: one and a half hour
description: Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.
measure: Correlation of lactate results to resting Ankle to brachial index (ABI)
time frame: one and a half hour
description: Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..
arm group label: Patients undergoing exercise oximetry
description: Patients with PAD referred for treadmill testing and exercise oximetry
intervention type: Diagnostic Test
intervention name: Exercise oximetry
description: Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
arm group label: Patients undergoing exercise oximetry
other name: Capillary blood sampling from the earlobe
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre ABRAHAM, MD; PhD
role: Principal Investigator
affiliation: University Hospitaml in Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Intermittent Claudication
sharing ipd: Undecided