Venous Disease in Pediatric Population (VEDIPEDI)

University of Catanzaro

Status: Unknown

Conditions: Pediatric ALL; Chronic Venous Insufficiency

Treatments: Diagnostic Test: In-office vascular visit; Diagnostic Test: Echo Duplex of lower limbs

Study type: Observational

Funder types: Other

Identifiers

NCT04424095

ER.ALL.2018.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

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.

Treatment:

Diagnostic Test: In-office vascular visit

Diagnostic Test: Echo Duplex of lower limbs