<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/NCT04404699</url>
  </required_header>
  <id_info>
    <org_study_id>TcPO2SDN</org_study_id>
    <nct_id>NCT04404699</nct_id>
  </id_info>
  <brief_title>Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot</brief_title>
  <acronym>stimTcPO2</acronym>
  <official_title>Stimulation Testing Performed During TcPO2 Measurement Improve the Diagnosis of Peripheral Arterial Disease in Patients With Diabetic Foot: A Multicentre Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>General University Hospital in Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Motol University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical and Experimental Medicine</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>
      All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are&#xD;
      limited due to diabetes mellitus and its late complications. The aim of our study is to&#xD;
      refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry&#xD;
      (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with diabetic foot and mild to moderate PAD (WIfI - Ischemia 1 or 2) with baseline&#xD;
      TcPO2 values 30-50 mmHg will be included into the study. TcPO2 will be measured on the feet&#xD;
      in different angiosomes. During this measurement a stimulation test consisting of a modified&#xD;
      Ratschow test involving 2 minutes of exercise will be conducted. Specific TcPO2 parameters&#xD;
      will be assessed during the whole procedure (resting TcPO2 before stimulation test, minimal&#xD;
      TcPO2, delta TcPO2 (minimum TcPo2 minus resting TcPO2) percentage decrease of TcPO2 during&#xD;
      the stimulation test and TcPO2 recovery time (time to the adjustment of TcPO2 to the resting&#xD;
      values).&#xD;
&#xD;
      All TcPO2 parameters detected during TcPO2 stimulation test will be correlated with&#xD;
      parameters of macrocirculation (systolic blood pressures (SBP) on tibial arteries and their&#xD;
      Ankle-Brachial Indexes (ABI), toe pressures (TP) and toe-brachial indexesTBI) and DUS&#xD;
      findings (monophasic/triphasic flow in relevant artery supplying measured angiosome)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Changes in TcPO2</measure>
    <time_frame>30 minutes</time_frame>
    <description>How change special parameters evaluated during Stimulation TcPO2 test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow</measure>
    <time_frame>30 minutes</time_frame>
    <description>A correlation of special parameters detected during Stimulation TcPO2 test with the type of arterial flow in large vessels supplying measured angiosome by TcPO2 will be performed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of stimulation TcPO2 parameters with macrocirculation parameters</measure>
    <time_frame>30 minutes</time_frame>
    <description>A correlation of special parameters detected during Stimulation TcPO2 test with the large vessels parameters usually used for PAD diagnosis (systolic blood pressures on ADP, PTA and their ABI and toe pressures and their TBI</description>
  </secondary_outcome>
  <enrollment type="Actual">79</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Stimulation TcPO2 test</intervention_name>
    <description>During measurement of TcPO2 in various angiosomes the stimulation test will be performed. We modify the Ratschow test (elevation of the lower limbs, rhythmic flexion and extension in talocrural joints for 2 minutes, then return to horizontal position). TcPO2 is measured continuously. Depending on the type of detected flows by DUS in the evaluated arteries supplying the relevant angiosome, in which TcPO2 values are measured, the patients and their angiosomes will be divided into 2 baseline groups - group M with monophasic flows or arterial obliterations and group T with triphasic flows.&#xD;
We will compare macrocirculation parameters-systolic pressure on dorsalis pedis artery (DPA), posterior tibial artery (PTA) and their doppler indexes. The resting TcPO2, the minimal TcPO2 found during the stimulation test, their delta (resting TcPO2 - minimal TcPO2) and the percentage decrease in TcPO2 will be compared between the study groups, as well as the duration of TcPO2 recovery.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with diabetic foot treated in out-patient foot clinic predominantly for diabetic&#xD;
        foot ulcers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of Diabetic Foot in patients with type 1 or type 2 diabetes mellitus, with&#xD;
             WIfI classification of ischemia 1-2 (based on TcPO2) without previously diagnosed PAD&#xD;
             or with known PAD based on the patients' history or previous vascular reconstruction&#xD;
             (endovascular or surgical vascular interventions)&#xD;
&#xD;
          -  resting TcPO2 values between 30-50 mm Hg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vascular interventions on evaluated limb within 12 months prior to the enrolment into&#xD;
             the study&#xD;
&#xD;
          -  factors possibly influencing for example oxygen saturation or feet movement:&#xD;
&#xD;
               -  patient imobility&#xD;
&#xD;
               -  impairment of movements at the talocrural joints&#xD;
&#xD;
               -  vasculitis&#xD;
&#xD;
               -  heart failure or advanced COPD&#xD;
&#xD;
               -  severe anaemia (plasma haemoglobin below 8g / dL)&#xD;
&#xD;
               -  hypoperfusion due to shock or cardiac dysfunction&#xD;
&#xD;
               -  sepsis&#xD;
&#xD;
               -  massive swelling of the lower limbs of various ethiology (including lymphedema)&#xD;
&#xD;
               -  active Charcot osteoarthropathy&#xD;
&#xD;
               -  critical limb ischemia with WIfI classification of ischemia 3&#xD;
&#xD;
               -  lower limb claudication below 200m&#xD;
&#xD;
               -  venous insufficiency of CEAP classification 6&#xD;
&#xD;
               -  severe diabetic kidney disease (CKD stage 4 or 5)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>IKEM</name>
      <address>
        <city>Prague</city>
        <zip>14021</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Clinical and Experimental Medicine</investigator_affiliation>
    <investigator_full_name>Vladimíra Fejfarová</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>diabetic foot</keyword>
  <keyword>peripheral arterial disease</keyword>
  <keyword>TcPO2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <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/NCT04404699
org study id: TcPO2SDN
nct id: NCT04404699
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are
      limited due to diabetes mellitus and its late complications. The aim of our study is to
      refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry
      (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot.
Patients with diabetic foot and mild to moderate PAD (WIfI - Ischemia 1 or 2) with baseline
      TcPO2 values 30-50 mmHg will be included into the study. TcPO2 will be measured on the feet
      in different angiosomes. During this measurement a stimulation test consisting of a modified
      Ratschow test involving 2 minutes of exercise will be conducted. Specific TcPO2 parameters
      will be assessed during the whole procedure (resting TcPO2 before stimulation test, minimal
      TcPO2, delta TcPO2 (minimum TcPo2 minus resting TcPO2) percentage decrease of TcPO2 during
      the stimulation test and TcPO2 recovery time (time to the adjustment of TcPO2 to the resting
      values).

      All TcPO2 parameters detected during TcPO2 stimulation test will be correlated with
      parameters of macrocirculation (systolic blood pressures (SBP) on tibial arteries and their
      Ankle-Brachial Indexes (ABI), toe pressures (TP) and toe-brachial indexesTBI) and DUS
      findings (monophasic/triphasic flow in relevant artery supplying measured angiosome)
observational model: Cohort
time perspective: Other
measure: Changes in TcPO2
time frame: 30 minutes
description: How change special parameters evaluated during Stimulation TcPO2 test
measure: Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow
time frame: 30 minutes
description: A correlation of special parameters detected during Stimulation TcPO2 test with the type of arterial flow in large vessels supplying measured angiosome by TcPO2 will be performed
measure: Correlation of stimulation TcPO2 parameters with macrocirculation parameters
time frame: 30 minutes
description: A correlation of special parameters detected during Stimulation TcPO2 test with the large vessels parameters usually used for PAD diagnosis (systolic blood pressures on ADP, PTA and their ABI and toe pressures and their TBI
intervention type: Diagnostic Test
intervention name: Stimulation TcPO2 test
description: During measurement of TcPO2 in various angiosomes the stimulation test will be performed. We modify the Ratschow test (elevation of the lower limbs, rhythmic flexion and extension in talocrural joints for 2 minutes, then return to horizontal position). TcPO2 is measured continuously. Depending on the type of detected flows by DUS in the evaluated arteries supplying the relevant angiosome, in which TcPO2 values are measured, the patients and their angiosomes will be divided into 2 baseline groups - group M with monophasic flows or arterial obliterations and group T with triphasic flows.
We will compare macrocirculation parameters-systolic pressure on dorsalis pedis artery (DPA), posterior tibial artery (PTA) and their doppler indexes. The resting TcPO2, the minimal TcPO2 found during the stimulation test, their delta (resting TcPO2 - minimal TcPO2) and the percentage decrease in TcPO2 will be compared between the study groups, as well as the duration of TcPO2 recovery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
facility: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Institute for Clinical and Experimental Medicine
investigator full name: Vladimíra Fejfarová
investigator title: Principal investigator
mesh term: Diabetic Foot
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases