Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Venous Disease in Pediatric Population (VEDIPEDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424095
Recruitment Status : Unknown
Verified June 2020 by Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro.
Recruitment status was:  Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Raffaele Serra, MD, Ph.D., 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.

Condition or disease Intervention/treatment
Chronic Venous Insufficiency Pediatric ALL Diagnostic Test: In-office vascular visit Diagnostic Test: Echo Duplex of lower limbs

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Chronic Venous Disease in Pediatric Population
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020


Group/Cohort Intervention/treatment
Pediatric patients
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.
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.




Primary Outcome Measures :
  1. Prevalence of Chronic Venous Disease [ Time Frame: at 9 month ]
    The Prevalence of Chronic Venous Disease in the population study will be assessed.

  2. Echo duplex evaluation [ Time Frame: at 10 month ]
    The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424095


Contacts
Layout table for location contacts
Contact: Raffaele Serra, M.D., Ph.D. +3909613647380 rserra@unicz.it

Locations
Layout table for location information
Italy
University Magna Graecia of Catanzaro Recruiting
Catanzaro, Italy, 88100
Contact: Raffaele Serra, M.D., Ph.D.    +3909613647380    rserra@unicz.it   
Sponsors and Collaborators
University of Catanzaro
Investigators
Layout table for investigator information
Principal Investigator: Raffaele Serra, M.D., Ph.D. University Magna Graecia of Catanzaro
Publications:
Layout table for additonal information
Responsible Party: Prof. Raffaele Serra, MD, Ph.D., Associate Professor of Vascular Surgery, University of Catanzaro
ClinicalTrials.gov Identifier: NCT04424095    
Other Study ID Numbers: ER.ALL.2018.21
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro:
Chronic venous disease
Pediatrics
vein reflux
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases