<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/NCT03810469</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01</org_study_id>
    <nct_id>NCT03810469</nct_id>
  </id_info>
  <brief_title>Foot Perfusion Analysis to Predict Limb Salvage</brief_title>
  <acronym>DELTA-PERF</acronym>
  <official_title>Perfusion Analysis of the Foot in Patients With Critical Limb Ischemia Before and After Revascularization and Predictive Value on Amputation-free Survival</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier de Valenciennes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier de Valenciennes</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>
      This study aims at evaluating the correlation between foot perfusion on angiographies&#xD;
      performed before and after revascularization and limb salvage in patients with critical limb&#xD;
      ischemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is&#xD;
      already recognized as a major health issue. CLI is frequently leading to major amputations.&#xD;
      Therefore, one of the key point to prevent limb loss is to restore a good vascularization to&#xD;
      the foot, usually thanks to endovascular means.&#xD;
&#xD;
      No consensual indicator is currently available to estimate if the limb revascularization will&#xD;
      be sufficient or not to prevent amputation, and to help physicians decide if they should be&#xD;
      more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the&#xD;
      ankle-brachial index (ABI) are commonly used in the ward (not available in the operating&#xD;
      room), but have shown poor correlation to wound healing or limb salvage and results are&#xD;
      frequently biased because of the arterial wall calcifications due to diabetes. Value of the&#xD;
      first toe systolic pressure is currently under evaluation to predict survival without&#xD;
      amputation, with promising results, but cannot be applied to patients with wounds at this&#xD;
      level or previous minor amputation.&#xD;
&#xD;
      The emergence of hybrid rooms in the operating theater offer access to high quality imaging&#xD;
      and image post-treatment. Those capabilities could be used to analyze the flow and the tissue&#xD;
      perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes,&#xD;
      such as wound healing, thus creating a useful tool to guide physicians in daily practice.&#xD;
&#xD;
      Differences between foot angiographies performed before and after revascularization could be&#xD;
      used to estimate the quality of the revascularization and predict wound healing and limb&#xD;
      salvage. This method would be directly available in the operating room and could help&#xD;
      physicians to optimize their strategy during the procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2, 2021</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Number of participants with major amputation</measure>
    <time_frame>1 month</time_frame>
    <description>Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with major amputation</measure>
    <time_frame>3 months</time_frame>
    <description>Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with major amputation</measure>
    <time_frame>6 months</time_frame>
    <description>Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with major amputation</measure>
    <time_frame>1 year</time_frame>
    <description>Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>1 month</time_frame>
    <description>Complete wound Healing at the level of the foot according to the WiFI classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>3 months</time_frame>
    <description>Complete wound Healing at the level of the foot according to the WiFI classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>6 months</time_frame>
    <description>Complete wound Healing at the level of the foot according to the WiFI classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>1 year</time_frame>
    <description>Complete wound Healing at the level of the foot according to the WiFI classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with secondary intervention</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants with a secondary intervention. Secondary intervention is defined as all secondary surgical interventions (both endovascular and open repairs) associated to critical limb ischemia on the same limb. It includes secondary angioplasties, bypasses or minor and major amputations. This is a clinical binary criterion (0= Freedom from secondary intervention, 1=At least one secondary intervention)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Overall Mortality, all-cause included</description>
  </secondary_outcome>
  <enrollment type="Actual">69</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <condition>Peripheral Arterial Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from peripheral arterial disease in critical limb ischemia (Rutherford&#xD;
        4, 5 and 6) at the initial presentation, with a major risk of limb amputation at mid-term&#xD;
        without revascularization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with critical limb ischemia Rutherford 4, 5 and 6, with at least one&#xD;
             pre-operative exam (CTA, magnetic resonance angiography or ultrasound) demonstrating a&#xD;
             peripheral arterial disease, and requiring an endovascular or hybrid (meaning combined&#xD;
             with a surgical technique) revascularization of the lower limb.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not willing to give their consent to study enrollment&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Patients with severe renal insufficiency (estimated creatinine clearance &lt; 30 mL/min),&#xD;
             without dialysis&#xD;
&#xD;
          -  Patients with life threatening septic wounds who would require an amputation at the&#xD;
             initial presentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CH Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Brownrigg JR, Apelqvist J, Bakker K, Schaper NC, Hinchliffe RJ. Evidence-based management of PAD &amp; the diabetic foot. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):673-81. doi: 10.1016/j.ejvs.2013.02.014. Epub 2013 Mar 27.</citation>
    <PMID>23540807</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang Z, Hasan R, Firwana B, Elraiyah T, Tsapas A, Prokop L, Mills JL Sr, Murad MH. A systematic review and meta-analysis of tests to predict wound healing in diabetic foot. J Vasc Surg. 2016 Feb;63(2 Suppl):29S-36S.e1-2. doi: 10.1016/j.jvs.2015.10.004.</citation>
    <PMID>26804365</PMID>
  </results_reference>
  <results_reference>
    <citation>Wickstrom JE, Laivuori M, Aro E, Sund RT, Hautero O, Venermo M, Jalkanen J, Hakovirta H. Toe Pressure and Toe Brachial Index are Predictive of Cardiovascular Mortality, Overall Mortality, and Amputation Free Survival in Patients with Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 May;53(5):696-703. doi: 10.1016/j.ejvs.2017.02.012. Epub 2017 Mar 11.</citation>
    <PMID>28292565</PMID>
  </results_reference>
  <results_reference>
    <citation>Brownrigg JR, Hinchliffe RJ, Apelqvist J, Boyko EJ, Fitridge R, Mills JL, Reekers J, Shearman CP, Zierler RE, Schaper NC; International Working Group on the Diabetic Foot. Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:128-35. doi: 10.1002/dmrr.2704.</citation>
    <PMID>26342129</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>limb salvage</keyword>
  <keyword>foot perfusion</keyword>
  <keyword>hybrid room</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>
  <!-- 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/NCT03810469
org study id: 2018-01
nct id: NCT03810469
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims at evaluating the correlation between foot perfusion on angiographies
      performed before and after revascularization and limb salvage in patients with critical limb
      ischemia.
Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is
      already recognized as a major health issue. CLI is frequently leading to major amputations.
      Therefore, one of the key point to prevent limb loss is to restore a good vascularization to
      the foot, usually thanks to endovascular means.

      No consensual indicator is currently available to estimate if the limb revascularization will
      be sufficient or not to prevent amputation, and to help physicians decide if they should be
      more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the
      ankle-brachial index (ABI) are commonly used in the ward (not available in the operating
      room), but have shown poor correlation to wound healing or limb salvage and results are
      frequently biased because of the arterial wall calcifications due to diabetes. Value of the
      first toe systolic pressure is currently under evaluation to predict survival without
      amputation, with promising results, but cannot be applied to patients with wounds at this
      level or previous minor amputation.

      The emergence of hybrid rooms in the operating theater offer access to high quality imaging
      and image post-treatment. Those capabilities could be used to analyze the flow and the tissue
      perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes,
      such as wound healing, thus creating a useful tool to guide physicians in daily practice.

      Differences between foot angiographies performed before and after revascularization could be
      used to estimate the quality of the revascularization and predict wound healing and limb
      salvage. This method would be directly available in the operating room and could help
      physicians to optimize their strategy during the procedure
observational model: Cohort
time perspective: Prospective
measure: Number of participants with major amputation
time frame: 1 month
description: Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
measure: Number of participants with major amputation
time frame: 3 months
description: Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
measure: Number of participants with major amputation
time frame: 6 months
description: Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
measure: Number of participants with major amputation
time frame: 1 year
description: Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)
measure: Wound Healing
time frame: 1 month
description: Complete wound Healing at the level of the foot according to the WiFI classification
measure: Wound Healing
time frame: 3 months
description: Complete wound Healing at the level of the foot according to the WiFI classification
measure: Wound Healing
time frame: 6 months
description: Complete wound Healing at the level of the foot according to the WiFI classification
measure: Wound Healing
time frame: 1 year
description: Complete wound Healing at the level of the foot according to the WiFI classification
measure: Number of patients with secondary intervention
time frame: 1 year
description: Number of participants with a secondary intervention. Secondary intervention is defined as all secondary surgical interventions (both endovascular and open repairs) associated to critical limb ischemia on the same limb. It includes secondary angioplasties, bypasses or minor and major amputations. This is a clinical binary criterion (0= Freedom from secondary intervention, 1=At least one secondary intervention)
measure: Overall Mortality
time frame: 1 year
description: Overall Mortality, all-cause included
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Brownrigg JR, Apelqvist J, Bakker K, Schaper NC, Hinchliffe RJ. Evidence-based management of PAD & the diabetic foot. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):673-81. doi: 10.1016/j.ejvs.2013.02.014. Epub 2013 Mar 27.
PMID: 23540807
citation: Wang Z, Hasan R, Firwana B, Elraiyah T, Tsapas A, Prokop L, Mills JL Sr, Murad MH. A systematic review and meta-analysis of tests to predict wound healing in diabetic foot. J Vasc Surg. 2016 Feb;63(2 Suppl):29S-36S.e1-2. doi: 10.1016/j.jvs.2015.10.004.
PMID: 26804365
citation: Wickstrom JE, Laivuori M, Aro E, Sund RT, Hautero O, Venermo M, Jalkanen J, Hakovirta H. Toe Pressure and Toe Brachial Index are Predictive of Cardiovascular Mortality, Overall Mortality, and Amputation Free Survival in Patients with Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 May;53(5):696-703. doi: 10.1016/j.ejvs.2017.02.012. Epub 2017 Mar 11.
PMID: 28292565
citation: Brownrigg JR, Hinchliffe RJ, Apelqvist J, Boyko EJ, Fitridge R, Mills JL, Reekers J, Shearman CP, Zierler RE, Schaper NC; International Working Group on the Diabetic Foot. Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:128-35. doi: 10.1002/dmrr.2704.
PMID: 26342129
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia