NCT04424095

Venous Disease in Pediatric Population

Investigation of Chronic Venous Disease in Pediatric Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Venous Insufficiency
• Pediatric ALL

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	In-office vascular visit	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_TEST	Echo Duplex of lower limbs	The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-09-01
• Completion: 2020-10-01
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Italy