<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/NCT04424095</url>
  </required_header>
  <id_info>
    <org_study_id>ER.ALL.2018.21</org_study_id>
    <nct_id>NCT04424095</nct_id>
  </id_info>
  <brief_title>Venous Disease in Pediatric Population</brief_title>
  <acronym>VEDIPEDI</acronym>
  <official_title>Investigation of Chronic Venous Disease in Pediatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catanzaro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Catanzaro</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Chronic venous disease (CVD) is widespread in adult subjects of western countries and is&#xD;
      responsible of important morbidity and healthcare costs. CVD has never been extensively&#xD;
      studied in pediatric population where the early pathophysiological alterations may occur&#xD;
      undetected. The aim of this study is to assess the prevalence of CVD searching also for the&#xD;
      early clinical and instrumental signs of this disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population&#xD;
      represents one of the main causes of morbidity in western countries, and it has also an&#xD;
      important effect on healthcare cost absorbing 1-2% of the total health budget in western&#xD;
      countries. Clinical manifestations related to CVD are well documented in adults, with&#xD;
      clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a&#xD;
      scarcity of published data regarding CVD in children, and in addition, venous duplex&#xD;
      ultrasound test of the lower limbs is performed much less commonly in children than in&#xD;
      adults.&#xD;
&#xD;
      Therefore, the natural history of pediatric venous reflux remains unclear, although it is&#xD;
      possible that it precedes the onset of CVD in adulthood. In this context, this observational&#xD;
      study aims to identify the presence of venous reflux, as well as clinical and morphological&#xD;
      data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular&#xD;
      visit and an echo duplex scan of lower limbs. The endpoints of this study are to&#xD;
      prospectively assess the prevalence of CVD in children, as well as to evaluate a possible&#xD;
      correlation between vein diameter and pathological vein reflux.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Prevalence of Chronic Venous Disease</measure>
    <time_frame>at 9 month</time_frame>
    <description>The Prevalence of Chronic Venous Disease in the population study will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Echo duplex evaluation</measure>
    <time_frame>at 10 month</time_frame>
    <description>The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Venous Insufficiency</condition>
  <condition>Pediatric ALL</condition>
  <arm_group>
    <arm_group_label>Pediatric patients</arm_group_label>
    <description>Recruited pediatric patients will undergo an in-office vascular visit and an echo duplex scan of lower limbs, in order to detect any symptoms or signs related to chronic venous disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>In-office vascular visit</intervention_name>
    <description>The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)</description>
    <arm_group_label>Pediatric patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echo Duplex of lower limbs</intervention_name>
    <description>The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.</description>
    <arm_group_label>Pediatric patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for&#xD;
        visit and diagnostic testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric Patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mental retardation&#xD;
&#xD;
          -  Patients with Marfan syndrome&#xD;
&#xD;
          -  Patients with an inability to stand or collaborate for the clinical tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Magna Graecia of Catanzaro</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
    <phone>+3909613647380</phone>
    <email>rserra@unicz.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Magna Graecia of Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
      <phone>+3909613647380</phone>
      <email>rserra@unicz.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.</citation>
    <PMID>18467617</PMID>
  </reference>
  <reference>
    <citation>Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.</citation>
    <PMID>15723761</PMID>
  </reference>
  <reference>
    <citation>Griffiths L, Vasudevan V, Myers A, Morganstern BA, Palmer LS. The role of inheritance in the development of adolescent varicoceles. Transl Androl Urol. 2018 Dec;7(6):920-925. doi: 10.21037/tau.2018.09.02.</citation>
    <PMID>30505728</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catanzaro</investigator_affiliation>
    <investigator_full_name>Prof. Raffaele Serra, MD, Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor of Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Chronic venous disease</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>vein reflux</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venous Insufficiency</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/NCT04424095
org study id: ER.ALL.2018.21
nct id: NCT04424095
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic venous disease (CVD) is widespread in adult subjects of western countries and is
      responsible of important morbidity and healthcare costs. CVD has never been extensively
      studied in pediatric population where the early pathophysiological alterations may occur
      undetected. The aim of this study is to assess the prevalence of CVD searching also for the
      early clinical and instrumental signs of this disease.
Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population
      represents one of the main causes of morbidity in western countries, and it has also an
      important effect on healthcare cost absorbing 1-2% of the total health budget in western
      countries. Clinical manifestations related to CVD are well documented in adults, with
      clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a
      scarcity of published data regarding CVD in children, and in addition, venous duplex
      ultrasound test of the lower limbs is performed much less commonly in children than in
      adults.

      Therefore, the natural history of pediatric venous reflux remains unclear, although it is
      possible that it precedes the onset of CVD in adulthood. In this context, this observational
      study aims to identify the presence of venous reflux, as well as clinical and morphological
      data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular
      visit and an echo duplex scan of lower limbs. The endpoints of this study are to
      prospectively assess the prevalence of CVD in children, as well as to evaluate a possible
      correlation between vein diameter and pathological vein reflux.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of Chronic Venous Disease
time frame: at 9 month
description: The Prevalence of Chronic Venous Disease in the population study will be assessed.
measure: Echo duplex evaluation
time frame: at 10 month
description: The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population
arm group label: Pediatric patients
description: Recruited pediatric patients will undergo an in-office vascular visit and an echo duplex scan of lower limbs, in order to detect any symptoms or signs related to chronic venous disease.
intervention type: Diagnostic Test
intervention name: In-office vascular visit
description: The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)
arm group label: Pediatric patients
intervention type: Diagnostic Test
intervention name: Echo Duplex of lower limbs
description: The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.
arm group label: Pediatric patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: No
last name: Raffaele Serra, M.D., Ph.D.
role: Principal Investigator
affiliation: University Magna Graecia of Catanzaro
last name: Raffaele Serra, M.D., Ph.D.
phone: +3909613647380
email: rserra@unicz.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
PMID: 18467617
citation: Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
PMID: 15723761
citation: Griffiths L, Vasudevan V, Myers A, Morganstern BA, Palmer LS. The role of inheritance in the development of adolescent varicoceles. Transl Androl Urol. 2018 Dec;7(6):920-925. doi: 10.21037/tau.2018.09.02.
PMID: 30505728
responsible party type: Principal Investigator
investigator affiliation: University of Catanzaro
investigator full name: Prof. Raffaele Serra, MD, Ph.D.
investigator title: Associate Professor of Vascular Surgery
mesh term: Venous Insufficiency
sharing ipd: No