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Outcomes of Different Treatment Options in Chronic Venous Disease

ConditionChronic Venous Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial population

Patients suffering from chronic venous disease who did not receive any dedicated treatment for CVD 3 months prior to inclusion

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiofrequency ablation using Closure fast

    Procedure/Surgery

    Thermal ablation technique

  • Aethoxysclerol

    Procedure/Surgery

    sclero-or foamsclerose

  • Daflon

    Drug

    Venoactive drugs

  • Compression stocking

    Device

    Compression

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: conservative2 interventions
Group B: invasive2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
baseline to 12 weeks

Secondary outcomes

1

Intervention as secondary/add-on treatment

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

Time frame
month 24
2

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

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

Time frame
through study completion, an average of 2 years
3

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

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

Time frame
through study completion, an average of 2 years
4

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

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

Time frame
through study completion, an average of 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: