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NCT Number: NCT06318988

Outcomes of Different Treatment Options in Chronic Venous Disease

This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with CVD in Belgium. The inclusion period of the study will last 6 months. Patients will be followed until 2 years after inclusion into the study.

During the inclusion period, after confirmation of eligibility, patients with CVD diagnosed by the General Practitioner (GP) and requiring a treatment will be invited to participate in the study. About 140 GPs across Belgium will be included in the study. During the first visit, a treatment strategy will be proposed to the patient by the GP. The treatment can be conservative or invasive, depending on the severity of the disease. Patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. The choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. As this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient visiting a GP with complaints related to CVD,
  • Patient receiving the diagnosis of CVD from the GP during the V0, according to international guidelines and made on a clinical basis,
  • Patient requiring and agreeing to receive conservative or invasive treatment,
  • French or Dutch speaking patient,
  • Patient signed informed consent and agrees to take part in the study and follow-up.

Exclusion criteria

  • Patient with coagulation disorders such as thrombophilia and/or taking anticoagulation drugs,
  • Pregnant or breastfeeding patient,
  • Patient with severe Peripheral Arterial Occlusive Disease (POAD), with Ankle Brachial Index (ABI) < 0.8,
  • Patient with malignancy,
  • Patient with neurological disorder or dementia,
  • Patients taking regular treatment for CVD 3 months prior to inclusion (except painkillers or anti-inflammatory drugs if taken for reasons other than CVD),
  • Patient in any other clinical study for any pharmaceutical product within 4 weeks preceding study inclusion,
  • Patient with any comorbidity or situation preventing a follow-up of 2 years.

Treatment and study plan

Radiofrequency ablation using Closure fast

Procedure

Thermal ablation technique

Other names: Laserablation using laser fiber

Aethoxysclerol

Procedure

sclero-or foamsclerose

Other names: polidocanol

Daflon

Drug

Venoactive drugs

Other names: Venoruton, Antistax

Compression stocking

Device

Compression

Primary outcomes

  1. Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score

    Time frame: baseline to 12 weeks

    Chronic Venous Insufficiency QOL questionnaire-20 score, min 20 max 100, higher means worse outcome

Secondary outcomes

  1. Intervention as secondary/add-on treatment

    Time frame: month 24

    Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment

  2. The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20)

    Time frame: through study completion, an average of 2 years

    The change in the CIVIQ-20 over time; min 20 max 100, higher means worse outcome

  3. The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification)

    Time frame: through study completion, an average of 2 years

    The change in the clinical part of the CEAP classification over time, min C0, max C6, higher means worse outcome

  4. The change in the revised Venous Clinical Severity Score (rVCSS)

    Time frame: through study completion, an average of 2 years

    The change in the rVCSS over time; min 0 max 30, higher means worse outcome

  5. The change in the symptoms, recorded with a questionnaire

    Time frame: through study completion, an average of 2 years

    The change in the symptomatology over time, recorded with a questionnaire

  6. The change in satisfaction score

    Time frame: through study completion, an average of 2 years

    The change in satisfaction score over time, min 0, max 10; higher means better outcome

  7. Adverse Events (AEs).

    Time frame: month 24

    Number and proportion of patients with Adverse Events (AEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah THOMIS, PhD

CONTACT

[email protected]

+32498296629

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium

Acronym: VOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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