Chronic Venous InsufficiencyVEDIPEDINCT04424095
Venous Disease in Pediatric Population
An observational study of Chronic Venous Insufficiency and Pediatric ALL, run by University of Catanzaro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Chronic Venous Insufficiency, Pediatric ALL
- What is being tested?
- In-office vascular visit and Echo Duplex of lower limbs
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.
Who may be able to join
- Pediatric Patients
Who cannot join
- Patients with mental retardation
- Patients with Marfan syndrome
- Patients with an inability to stand or collaborate for the clinical tests.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, 88100
Raffaele Serra, M.D., Ph.D., +3909613647380, rserra@unicz.it
About this study
Official title: Investigation of Chronic Venous Disease in Pediatric Population
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.
Read the 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
- Being tested
- In-office vascular visit, Echo Duplex of lower limbs
- Keywords
- Chronic venous disease, Pediatrics, vein reflux
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-office vascular visitDiagnostic test
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 limbsDiagnostic test
The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: In-office vascular visit; Diagnostic Test: Echo Duplex of lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Chronic Venous Disease
The Prevalence of Chronic Venous Disease in the population study will be assessed.
Measured: at 9 month
Echo duplex evaluation
The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population
Measured: at 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Feb 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., Ph.D., Principal investigator, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424095
- Sponsor's protocol ID
- ER.ALL.2018.21
- Acronym
- VEDIPEDI
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
PubMed 18467617Beebe-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. doi: 10.1016/j.annepidem.2004.05.015.
PubMed 15723761Griffiths 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.
PubMed 30505728
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Chronic Venous Disease in Pediatric Population
- ClinicalTrials.gov ID
- NCT04424095
- Acronym / sponsor ID
- VEDIPEDI / ER.ALL.2018.21
- Conditions
- Chronic Venous Insufficiency, Pediatric ALL
- Keywords
- Chronic venous disease, Pediatrics, vein reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: In-office vascular visit, Diagnostic Test: Echo Duplex of lower limbsRecruited 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. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.
Key inclusion criteria (1 listed)
- Pediatric Patients
Key exclusion criteria (3 listed)
- Patients with mental retardation
- Patients with Marfan syndrome
- Patients with an inability to stand or collaborate for the clinical tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-office vascular visitThe 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 | Pediatric patients |
| Echo Duplex of lower limbsThe venous system of lower limbs will be checked in order to detect any vein dilation and reflux. | Diagnostic test | Pediatric patients |
Primary outcome
Prevalence of Chronic Venous Disease
Time frame: at 9 month
The Prevalence of Chronic Venous Disease in the population study will be assessed.
Echo duplex evaluation
Time frame: at 10 month
The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 18467617Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
- Background: PubMed 15723761Beebe-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. doi: 10.1016/j.annepidem.2004.05.015.
- Background: PubMed 30505728Griffiths 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., Ph.D. principal investigator
University Magna Graecia of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency and Pediatric ALL, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Serra, M.D., Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chronic Venous Disease (time frame: at 9 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424095, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.