<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/NCT03012750</url>
  </required_header>
  <id_info>
    <org_study_id>SPY-Angiosome</org_study_id>
    <nct_id>NCT03012750</nct_id>
  </id_info>
  <brief_title>Angiosome Perfusion After Tibial Bypass</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Erlangen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Erlangen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microcirculation should be assessed before and after tibial bypass surgery by intraoperative&#xD;
      fluorescence angiography. According to this, the direct and the indirect angiosomes should be&#xD;
      compared according to the individual microcirculatory improvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery&#xD;
      will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to&#xD;
      assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™,&#xD;
      NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect&#xD;
      revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and&#xD;
      Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing&#xD;
      rate is compared between the different revascularization methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</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>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)</measure>
    <time_frame>12 months</time_frame>
    <description>Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)</measure>
    <time_frame>12 months</time_frame>
    <description>Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of the wound healing rates with indirect and direct revascularization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>foot perfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous application of indocyanine green in patients receiving tibial Bypass surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine Green</intervention_name>
    <description>Perioperative application of 0.1 mg ICG per kg Body weight</description>
    <arm_group_label>foot perfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at CLI Rutherford stages IV to VI&#xD;
&#xD;
          -  Patients with necessity of tibial Bypass surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy against indocyanine green&#xD;
&#xD;
          -  Iodine allergy&#xD;
&#xD;
          -  Contrast allergy&#xD;
&#xD;
          -  Penicillin allergy&#xD;
&#xD;
          -  Allergic diathesis&#xD;
&#xD;
          -  Liver insufficiency&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hyperthyreosis&#xD;
&#xD;
          -  Pulmonary arterial hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Erlangen</investigator_affiliation>
    <investigator_full_name>Ulrich Rother</investigator_full_name>
    <investigator_title>Dr. med. Ulrich Rother, Principal Investigator</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>
  <!-- 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/NCT03012750
org study id: SPY-Angiosome
nct id: NCT03012750
lead sponsor: 
has dmc: No
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative
      fluorescence angiography. According to this, the direct and the indirect angiosomes should be
      compared according to the individual microcirculatory improvement.
Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery
      will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to
      assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™,
      NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect
      revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and
      Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing
      rate is compared between the different revascularization methods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
measure: Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)
time frame: 12 months
description: Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery
measure: Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)
time frame: 12 months
description: Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery
measure: Correlation of the wound healing rates with indirect and direct revascularization
time frame: 12 months
arm group label: foot perfusion
arm group type: Experimental
description: intravenous application of indocyanine green in patients receiving tibial Bypass surgery
intervention type: Drug
intervention name: Indocyanine Green
description: Perioperative application of 0.1 mg ICG per kg Body weight
arm group label: foot perfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Hospital Erlangen
investigator full name: Ulrich Rother
investigator title: Dr. med. Ulrich Rother, Principal Investigator
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases