<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/NCT04427124</url>
  </required_header>
  <id_info>
    <org_study_id>CA10142019</org_study_id>
    <nct_id>NCT04427124</nct_id>
  </id_info>
  <brief_title>The CLI-AMP Registry</brief_title>
  <acronym>CLI-AMP</acronym>
  <official_title>Impact of Multidisciplinary Critical Limb Ischemia Team on the Utilization of Vascular Studies, Patient Management, AMPutation and Long-term Outcomes: The CLI-AMP Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hendrick Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hendrick Medical Center</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>
      Single-center, observational registry study with a prospective and retrospective arm to&#xD;
      evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular&#xD;
      studies, revascularization, in-hospital and long-term outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is well known from large Medicare and National Inpatient Sample databases that vascular&#xD;
      evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains&#xD;
      extremely low. However, this data is largely pulled from the early 2000s with a scarcity in&#xD;
      studies from this recent decade. A recent study showed that Medicare patients from 2011&#xD;
      showed that 23% of patients received primary major amputation. In a recent retrospective&#xD;
      analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated&#xD;
      for vascular work up and long-term mortality. This cohort included 698 patients with 1009&#xD;
      amputated specimens (major and minor). This means that this institution is preforming around&#xD;
      140 amputations per year, which can be considered unacceptably high. Only 50% received any&#xD;
      form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography&#xD;
      angiography) within the year prior to amputation. Furthermore, only 30% of patients received&#xD;
      an angiogram within the year prior to amputation. In addition, all major amputations received&#xD;
      histopathological analysis, which confirmed that 62% the specimens were graded with severe&#xD;
      atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not&#xD;
      receiving proper evaluation and treatment leading to amputation which is associated with&#xD;
      extreme mortality rates and a large economic burden, health care facilities are not improving&#xD;
      their care.&#xD;
&#xD;
      Multidisciplinary teams are a recommendation from the American Heart Association/American&#xD;
      College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary&#xD;
      team approaches in other cardiovascular diseases, such as structural heart disease, has long&#xD;
      been validated. Literature regarding the implementation of &quot;CLI Teams&quot; remains scarce and not&#xD;
      widely adopted. However, institutions that have implemented a CLI Team that engages with&#xD;
      specialists from multiple disciplines have shown successful decrease in amputation rates and&#xD;
      increases in vascular evaluations and revascularization in these patients. The goal for this&#xD;
      study is to establish a hospital-based, physician and nurse led, multidisciplinary team to&#xD;
      deliver comprehensive care to CLI patients. We believe it is important to document the&#xD;
      experience of building a CLI Team and care protocols to provide insight and validated data&#xD;
      for other programs to implement. The multidisciplinary team will include vascular&#xD;
      interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology,&#xD;
      orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing&#xD;
      staff, and vascular technologists. The ultimate goal is amputation prevention and wound&#xD;
      healing through comprehensive vascular care and data driven patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Change in the number of major amputations within the hospital</measure>
    <time_frame>2 years</time_frame>
    <description>Decreased percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in in-hospital and long-term mortality rates</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the percentage of non-invasive vascular evaluations in patients with CLI and at risk for amputation (ABI, DUS, CTA)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of patients receiving invasive angiogram and revascularization (Endovascular or Surgical).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wound healing</measure>
    <time_frame>2 years</time_frame>
    <description>Decrease in Rutherford Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hospital length of stay</measure>
    <time_frame>2 years</time_frame>
    <description>Decrease in days</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <description>Patients admitted into the hospital will receive care based on a multidisciplinary team approach and Institutional critical limb ischemia protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Retrospective</arm_group_label>
    <description>A retrospective analysis of all patients with CLI admitted to the hospital from 2017-2019 will serve as a baseline comparator for overall CLI care and long-term mortality out to 2 years will be analyzed in the retrospective cohort using the national death index. Patients will be identified by the following ICD codes: 440.22 (ASVD of extremities with rest pain), 440.23 (ulceration), and 440.24 (gangrene).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary Team Based Care Model</intervention_name>
    <description>All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.</description>
    <arm_group_label>Prospective</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Critical Limb Ischemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  CLI of the lower extremity&#xD;
&#xD;
          -  Willingness and ability to participate in the study and meet follow-up requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  Incarcerated patients&#xD;
&#xD;
          -  Patients who receive amputations due to trauma or cancer&#xD;
&#xD;
          -  Wound, gangrene, or amputation of the upper extremities&#xD;
&#xD;
          -  Unwillingness or inability to participate in the study and meet follow-up requirements&#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_contact>
    <last_name>Bailey A Estes, BSN</last_name>
    <phone>325-207-4734</phone>
    <email>baileyann1123@gmail.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hendrick Medical Center</investigator_affiliation>
    <investigator_full_name>Joji Varghese</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Critical Limb Ischemia</keyword>
  <keyword>Peripheral Arterial Disease</keyword>
  <keyword>Amputation</keyword>
  <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>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</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/NCT04427124
org study id: CA10142019
nct id: NCT04427124
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single-center, observational registry study with a prospective and retrospective arm to
      evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular
      studies, revascularization, in-hospital and long-term outcomes.
It is well known from large Medicare and National Inpatient Sample databases that vascular
      evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains
      extremely low. However, this data is largely pulled from the early 2000s with a scarcity in
      studies from this recent decade. A recent study showed that Medicare patients from 2011
      showed that 23% of patients received primary major amputation. In a recent retrospective
      analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated
      for vascular work up and long-term mortality. This cohort included 698 patients with 1009
      amputated specimens (major and minor). This means that this institution is preforming around
      140 amputations per year, which can be considered unacceptably high. Only 50% received any
      form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography
      angiography) within the year prior to amputation. Furthermore, only 30% of patients received
      an angiogram within the year prior to amputation. In addition, all major amputations received
      histopathological analysis, which confirmed that 62% the specimens were graded with severe
      atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not
      receiving proper evaluation and treatment leading to amputation which is associated with
      extreme mortality rates and a large economic burden, health care facilities are not improving
      their care.

      Multidisciplinary teams are a recommendation from the American Heart Association/American
      College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary
      team approaches in other cardiovascular diseases, such as structural heart disease, has long
      been validated. Literature regarding the implementation of "CLI Teams" remains scarce and not
      widely adopted. However, institutions that have implemented a CLI Team that engages with
      specialists from multiple disciplines have shown successful decrease in amputation rates and
      increases in vascular evaluations and revascularization in these patients. The goal for this
      study is to establish a hospital-based, physician and nurse led, multidisciplinary team to
      deliver comprehensive care to CLI patients. We believe it is important to document the
      experience of building a CLI Team and care protocols to provide insight and validated data
      for other programs to implement. The multidisciplinary team will include vascular
      interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology,
      orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing
      staff, and vascular technologists. The ultimate goal is amputation prevention and wound
      healing through comprehensive vascular care and data driven patient outcomes.
observational model: Cohort
time perspective: Prospective
measure: Change in the number of major amputations within the hospital
time frame: 2 years
description: Decreased percentage
measure: Change in in-hospital and long-term mortality rates
time frame: 2 years
measure: Change in the percentage of non-invasive vascular evaluations in patients with CLI and at risk for amputation (ABI, DUS, CTA)
time frame: 2 years
measure: Change in percentage of patients receiving invasive angiogram and revascularization (Endovascular or Surgical).
time frame: 2 years
measure: Change in wound healing
time frame: 2 years
description: Decrease in Rutherford Classification
measure: Change in hospital length of stay
time frame: 2 years
description: Decrease in days
arm group label: Prospective
description: Patients admitted into the hospital will receive care based on a multidisciplinary team approach and Institutional critical limb ischemia protocol.
arm group label: Retrospective
description: A retrospective analysis of all patients with CLI admitted to the hospital from 2017-2019 will serve as a baseline comparator for overall CLI care and long-term mortality out to 2 years will be analyzed in the retrospective cohort using the national death index. Patients will be identified by the following ICD codes: 440.22 (ASVD of extremities with rest pain), 440.23 (ulceration), and 440.24 (gangrene).
intervention type: Other
intervention name: Multidisciplinary Team Based Care Model
description: All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.
arm group label: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bailey A Estes, BSN
phone: 325-207-4734
email: baileyann1123@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Hendrick Medical Center
investigator full name: Joji Varghese
investigator title: Principal Investigator
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: No