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Venous Disease in Pediatric Population

Investigation of Chronic Venous Disease in Pediatric Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04424095
Acronym
VEDIPEDI
Enrollment
100
Registered
2020-06-09
Start date
2020-02-01
Completion date
2020-10-01
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency, Pediatric ALL

Keywords

Chronic venous disease, Pediatrics, vein reflux

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.

Detailed description

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.

Interventions

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)

DIAGNOSTIC_TESTEcho Duplex of lower limbs

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

Sponsors

University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric Patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Chronic Venous Diseaseat 9 monthThe Prevalence of Chronic Venous Disease in the population study will be assessed.
Echo duplex evaluationat 10 monthThe correlation between veins diameter and the presence of reflux will be evaluated in pediatric population

Countries

Italy

Contacts

Primary ContactRaffaele Serra, M.D., Ph.D.
rserra@unicz.it+3909613647380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026