Brazilian Registry of Chronic Venous Disease - Risk Factors, Comorbidities, Clinical and Surgical Treatment (BRAVO)

January 16, 2026 updated by: Vinícius C Quintão, MD, MSc, PhD

Brazilian Registry of Chronic Venous Disease - Risk Factors, Comorbidities, Clinical and Surgical Treatment: BRAVO Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic venous disease (CVD), also known as chronic venous insufficiency in its advanced stages, is marked by dysfunction in the peripheral venous system of the lower extremities, often due to venous flow obstruction or reflux. Affecting approximately 25-45% of women and 10-40% of men, CVD significantly increases public health expenditures. While the exact mechanisms remain unclear, evidence suggests that CVD is multifactorial, involving heightened inflammation, valvular incompetence, and calf muscle dysfunction, all contributing to impaired venous return and elevated venous pressure.

Common symptoms include varicose veins, lower limb edema, leg discomfort, and heaviness. CVD is progressive and can advance from superficial vessel involvement, known as telangiectasia, to deep venous ulcers. Risk factors such as family history, prolonged standing, smoking, and obesity can contribute to its onset and progression. Conservative management focuses on lifestyle changes like exercise, weight control, limb elevation, and compression. Pharmacologic or surgical intervention may be necessary in advanced cases. Left untreated, CVD can severely impact patients' quality of life, hindering daily and work activities.

However, data on CVD prevalence in Brazil is limited, largely based on a single study by Maffei et al. in 1986, which found a 47.6% prevalence of varicose veins and a 3.6% prevalence of advanced CVD in 1,755 adults in Botucatu, São Paulo. To better serve Brazilian patients, further data on CVD prevalence, treatment, and risk factors is essential, aiding healthcare providers in optimizing patient care.

This study aims to characterize the clinical and epidemiological profile of Brazilian CVD patients through a multicenter, prospective observational study. Conducted across 10 centers nationwide, the study will recruit at least 65 patients per center over 12 weeks.

Quality of life will be assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ), with lower scores indicating better quality of life. The Venous Clinical Severity Score (VCSS) will gauge CVD severity, with higher scores indicating greater disease severity. VCSS correlates with the CEAP classification system and ultrasound findings.

CVD diagnoses will be categorized using the CEAP classification:

C0: No signs of venous disease C1: Telangiectasia/reticular veins C2: Varicose veins (≥3 mm diameter) C3: Edema C4: Skin/subcutaneous changes due to CVD, subdivided into C4a (pigmentation/eczema), C4b (lipodermatosclerosis/Atrophie Blanche), and C4c (corona phlebectatica) C5: Healed venous ulcer C6: Active venous ulcer C6r: Recurrent active venous ulcer During exams, patients will undergo physical evaluation for CVD signs, followed by duplex ultrasound of superficial and perforating veins. These will be conducted in both standing and supine positions by qualified vascular specialists, alongside personal medical history, demographics, occupation, physical stress, and varicose vein symptoms.

The study will measure factors including:

Presence and location of saphenous vein insufficiency, reflux, and vein caliber Presence of perforating veins and reflux characteristics Presence of deep vein thrombosis and related complications The study also covers therapeutic procedures such as sclerotherapy, endovenous ablation, and surgical vein removal. Compression stockings and pharmacological treatments (e.g., diosmin + hesperidin, calcium dobesilate, troxerutin) will be documented, including usage frequency and duration.

Data on cardiovascular diseases, comorbidities (e.g., hypertension, diabetes, dyslipidemia), occupation, and family history of CVD will also be collected, providing comprehensive insights into the risk and impact of CVD on the Brazilian population.

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 0543000
        • Hospital das Clínicas HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Single group
A single group will be included in this cross-sectional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classification of Venous Disease
Time Frame: Enrollment until Day 1

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aberdeen Varicose Vein Questionnaire
Time Frame: Enrollment until 24 hours
The quality of life assessment will be performed by the Aberdeen Varicose Vein Questionnaire (AVVQ), consisting of 13 questions totaling a score of 0 to 100 points.
Enrollment until 24 hours
Severity of chronic venous disease
Time Frame: Enrollment until 24 hours
The severity of chronic venous disease will be assessed by the Venous Clinical Severity Score (VCSS), which includes 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, ulcer size and use of compressive therapy) scored from 0 to 3 (0 = absent; 1= mild; 2= moderate; 3= severe), which can total 30 points.10 VCSS has been shown to have a positive correlation with CEAP and reflux/obstruction assessed by ultrasound.
Enrollment until 24 hours
Proportion of patients receiving treatment
Time Frame: Enrollment until 24 hours
Proportion of patients with chronic venous disease who receive clinical and/or surgical treatment
Enrollment until 24 hours
Proportion of associated comorbidities
Time Frame: Enrollment until 24 hours
Proportion of associated comorbidities in patients with chronic venous disease.
Enrollment until 24 hours
Risk factors rate
Time Frame: Enrollment until 24 hours
Describe the risk factors for the occurrence of chronic venous disease.
Enrollment until 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vinícius C Quintão, MD, MSc, PhD

Collaborators

University of Sao Paulo

Investigators

  • Principal Investigator: Rodrigo Kikuchi, MD, PhD, Santa Casa de Misericordia de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRAVO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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