NCT04424095

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 6, 2020

Last Update Submit

June 6, 2020

Conditions

Chronic Venous InsufficiencyPediatric ALL

Keywords

Chronic venous diseasePediatricsvein reflux

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Chronic Venous Disease

    The Prevalence of Chronic Venous Disease in the population study will be assessed.

    at 9 month

  • Echo duplex evaluation

    The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population

    at 10 month

Study Arms (1)

Pediatric patients

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.

Diagnostic Test: In-office vascular visitDiagnostic Test: Echo Duplex of lower limbs

Interventions

In-office vascular visitDIAGNOSTIC_TEST

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)

Pediatric patients
Echo Duplex of lower limbsDIAGNOSTIC_TEST

The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.

Pediatric patients

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.

You may qualify if:

  • Pediatric Patients

You may not qualify if:

  • Patients with mental retardation
  • Patients with Marfan syndrome
  • Patients with an inability to stand or collaborate for the clinical tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

  • Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.

    PMID: 18467617BACKGROUND

  • 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: 15723761BACKGROUND

  • 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: 30505728BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Raffaele Serra, M.D., Ph.D.

    University Magna Graecia of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Serra, M.D., Ph.D.

CONTACT

+3909613647380rserra@unicz.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Vascular Surgery

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 9, 2020

Study Start

February 1, 2020

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)