NCT06683586

Brief Summary

Chronic venous disease (CVD) is a widespread and challenging condition globally, encompassing the full range of anatomical and functional abnormalities in the venous system of the lower extremities. It is characterized by symptoms such as edema, skin changes, and venous ulcers, primarily caused by venous insufficiency with resulting reflux. CVD significantly impacts quality of life and imposes a considerable socioeconomic burden. Lifestyle factors play a critical role in the risk of developing CVD. In recent years, average body mass index (BMI) values have risen in Western countries, with obesity recognized as a major risk factor for CVD. Additional factors, including smoking, physical inactivity, and hypertension, are also linked to an increased risk of CVD and chronic venous insufficiency. There is a lack of recent Brazilian data on the prevalence and epidemiological characteristics of CVD, highlighting the need for this study. This research aims to gather national data on risk factors, associated comorbidities, and treatment types in Brazilian patients with CVD. The primary goal is to describe the clinical and epidemiological profile of CVD in the Brazilian population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

November 6, 2024

Last Update Submit

January 16, 2026

Conditions

Chronic Venous Disease

Keywords

Chronic Venous DiseaseRegistryVenous clinical severity score

Outcome Measures

Primary Outcomes (1)

  • Classification of Venous Disease

    Clinical Classification of Venous Disease system CEAP, clinical (C), etiological (E), anatomical (A) and pathological (P) classification as follows: C0 = No visible or palpable signs of venous disease; C1 = Telangiectasia or reticular veins; C2 = Varicose veins; distinguishable from reticular veins by a diameter ≥ 3 mm; C3 = Edema; C4 = Changes in skin and subcutaneous tissue secondary to CVD, subdivided into: C4a = Pigmentation or eczema; C4b = Lipodermatosclerosis or Atrophie Blanche; C4c = Corona phlebectatica; C5 = Cured venous ulcer; C6 = Active venous ulcer; C6r = Recurrent active venous ulcer.

    Enrollment until Day 1

Secondary Outcomes (5)

  • Aberdeen Varicose Vein Questionnaire

    Enrollment until 24 hours

  • Severity of chronic venous disease

    Enrollment until 24 hours

  • Proportion of patients receiving treatment

    Enrollment until 24 hours

  • Proportion of associated comorbidities

    Enrollment until 24 hours

  • Risk factors rate

    Enrollment until 24 hours

Study Arms (1)

Single group

A single group will be included in this cross-sectional study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥ 18 years) diagnosed with chronic venous disease.

You may qualify if:

  • Patients of both sexes diagnosed with chronic venous disease;
  • Age equal to or greater than 18 years;
  • Signature of the informed consent form.

You may not qualify if:

  • Non-agreement to participate in the study;
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas HCFMUSP

São Paulo, 0543000, Brazil

Location

Related Publications (10)

  • Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.

    PMID: 10842165RESULT

  • Staniszewska A, Tambyraja A, Afolabi E, Bachoo P, Brittenden J. The Aberdeen varicose vein questionnaire, patient factors and referral for treatment. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):715-8. doi: 10.1016/j.ejvs.2013.08.019. Epub 2013 Sep 7.

    PMID: 24119467RESULT

  • Maffei FH, Magaldi C, Pinho SZ, Lastoria S, Pinho W, Yoshida WB, Rollo HA. Varicose veins and chronic venous insufficiency in Brazil: prevalence among 1755 inhabitants of a country town. Int J Epidemiol. 1986 Jun;15(2):210-7. doi: 10.1093/ije/15.2.210.

    PMID: 3721683RESULT

  • Silva MJ, Louzada ACS, da Silva MFA, Portugal MFC, Teivelis MP, Wolosker N. Epidemiology of 869,220 varicose vein surgeries over 12 years in Brazil: trends, costs and mortality rate. Ann Vasc Surg. 2022 May;82:1-6. doi: 10.1016/j.avsg.2021.11.016. Epub 2021 Dec 20.

    PMID: 34942339RESULT

  • Araujo DN, Ribeiro CT, Maciel AC, Bruno SS, Fregonezi GA, Dias FA. Physical exercise for the treatment of non-ulcerated chronic venous insufficiency. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD010637. doi: 10.1002/14651858.CD010637.pub3.

    PMID: 37314059RESULT

  • Bradbury A, Evans C, Allan P, Lee A, Ruckley CV, Fowkes FG. What are the symptoms of varicose veins? Edinburgh vein study cross sectional population survey. BMJ. 1999 Feb 6;318(7180):353-6. doi: 10.1136/bmj.318.7180.353.

    PMID: 9933194RESULT

  • Nogueira JFL, Teixeira-Viana FC, Barboza-Silva BL, Mendes-Pinto D, Rodrigues-Machado MDG. Advanced Levels of Chronic Venous Insufficiency are Related to an Increased in Arterial Stiffness. Ann Vasc Surg. 2023 Oct;96:365-373. doi: 10.1016/j.avsg.2023.03.013. Epub 2023 Mar 31.

    PMID: 37003361RESULT

  • Bergan JJ, Pascarella L, Schmid-Schonbein GW. Pathogenesis of primary chronic venous disease: Insights from animal models of venous hypertension. J Vasc Surg. 2008 Jan;47(1):183-92. doi: 10.1016/j.jvs.2007.09.028.

    PMID: 18178472RESULT

  • Silva MFAD, Louzada ACS, Teivelis MP, Leiderman DBD, Portugal MFC, Stabellini N, Amaro Junior E, Wolosker N. Varicose Vein Stripping in 66,577 patients in 11 years in public hospitals in Sao Paulo. Rev Assoc Med Bras (1992). 2022 Nov 25;68(12):1657-1662. doi: 10.1590/1806-9282.20220565. eCollection 2022.

    PMID: 36449789RESULT

  • Chaitidis N, Kokkinidis DG, Papadopoulou Z, Kyriazopoulou M, Schizas D, Bakoyiannis C. Treatment of chronic venous disorder: A comprehensive review. Dermatol Ther. 2022 Feb;35(2):e15238. doi: 10.1111/dth.15238. Epub 2021 Dec 13.

    PMID: 34859549RESULT

Study Officials

  • Rodrigo Kikuchi, MD, PhD

    Santa Casa de Misericordia de Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 12, 2024

Study Start

October 18, 2024

Primary Completion

October 1, 2025

Study Completion

December 30, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

BR(1)