Venous Disease in Pediatric Population

Pediatric ALL Clinical Trial

— VEDIPEDI  

Official title:

Investigation of Chronic Venous Disease in Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424095
• Other study ID #: ER.ALL.2018.21
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2020
• Source: University of Catanzaro
• Contact: Raffaele Serra, M.D., Ph.D.
• Phone: +3909613647380
• Email: rserra[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Pediatric ALL
• Venous Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	University Magna Graecia of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Chronic Venous Disease	The Prevalence of Chronic Venous Disease in the population study will be assessed.	at 9 month
Primary	Echo duplex evaluation	The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population	at 10 month