Outcomes of Different Treatment Options in Chronic Venous Disease (VOS)

Universitaire Ziekenhuizen KU Leuven

Status

Not yet enrolling

Conditions

Chronic Venous Disease

Treatments

Drug: Daflon

Procedure: Aethoxysclerol

Procedure: Radiofrequency ablation using Closure fast

Device: Compression stocking

Study type

Observational

Funder types

Other

Identifiers

NCT06318988

S67030

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.