Venous Disease in Pediatric Population

• Conditions: Chronic Venous Insufficiency; Pediatric ALL
• Interventions: Diagnostic Test: In-office vascular visit; Diagnostic Test: Echo Duplex of lower limbs

• Registration Number: NCT04424095
• Lead Sponsor: University of Catanzaro

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.

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-06
• Last Update Submitted: 2020-06-06
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients	In-office vascular visit	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.
Pediatric patients	Echo Duplex of lower limbs	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of Chronic Venous Disease	at 9 month	The Prevalence of Chronic Venous Disease in the population study will be assessed.
Echo duplex evaluation	at 10 month	The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population

Trial Locations

Locations (1)

University Magna Graecia of Catanzaro; 🇮🇹 Catanzaro, Italy