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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conservative | compression therapy, and oral or topical venoactive drugs |
| |
| invasive | sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation using Closure fast | Procedure | Thermal ablation technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention as secondary/add-on treatment | Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment | month 24 |
| The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20) |
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Inclusion Criteria:
* Patient visiting a GP with complaints related to CVD,
Exclusion Criteria:
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Patients suffering from chronic venous disease who did not receive any dedicated treatment for CVD 3 months prior to inclusion
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah THOMIS, PhD | Contact | +32498296629 | sarah.thomis@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Thomis, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
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| ID | Term |
|---|---|
| D000077423 | Polidocanol |
| D004145 | Diosmin |
| C005865 | troxerutin |
| C522873 | Antistax |
| D053828 | Stockings, Compression |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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| Aethoxysclerol | Procedure | sclero-or foamsclerose |
|
|
| Daflon | Drug | Venoactive drugs |
|
|
| Compression stocking | Device | Compression |
|
The change in the CIVIQ-20 over time; min 20 max 100, higher means worse outcome
| through study completion, an average of 2 years |
| 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 | through study completion, an average of 2 years |
| 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 | through study completion, an average of 2 years |
| The change in the symptoms, recorded with a questionnaire | The change in the symptomatology over time, recorded with a questionnaire | through study completion, an average of 2 years |
| The change in satisfaction score | The change in satisfaction score over time, min 0, max 10; higher means better outcome | through study completion, an average of 2 years |
| Adverse Events (AEs). | Number and proportion of patients with Adverse Events (AEs). | month 24 |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058128 | Compression Bandages |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |