Chronic Venous Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERadiofrequency ablation using Closure fast
Thermal ablation technique
PROCEDUREAethoxysclerol
sclero-or foamsclerose
DRUGDaflon
Venoactive drugs
DEVICECompression stocking
Compression
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score | baseline to 12 weeks | Chronic Venous Insufficiency QOL questionnaire-20 score, min 20 max 100, higher means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) | through study completion, an average of 2 years | The change in the CIVIQ-20 over time; min 20 max 100, higher means worse outcome |
| The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification) | 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 |
| The change in the revised Venous Clinical Severity Score (rVCSS) | through study completion, an average of 2 years | The change in the rVCSS over time; min 0 max 30, higher means worse outcome |
| Intervention as secondary/add-on treatment | month 24 | Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment |
| The change in satisfaction score | through study completion, an average of 2 years | The change in satisfaction score over time, min 0, max 10; higher means better outcome |
| Adverse Events (AEs). | month 24 | Number and proportion of patients with Adverse Events (AEs). |
| The change in the symptoms, recorded with a questionnaire | through study completion, an average of 2 years | The change in the symptomatology over time, recorded with a questionnaire |
Contacts
Primary ContactSarah THOMIS, PhD
Outcome results
None listed