Clinical trial NCT06318988: Outcomes of Different Treatment Options in Chronic Venous Disease
Official title: An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Venous Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from chronic venous disease who did not receive any dedicated treatment for CVD 3 months prior to inclusion

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Intervention as secondary/add-on treatment
timeFrame: month 24
measure: The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20)
timeFrame: through study completion, an average of 2 years
measure: The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification)
timeFrame: through study completion, an average of 2 years
measure: The change in the revised Venous Clinical Severity Score (rVCSS)
timeFrame: through study completion, an average of 2 years
measure: The change in the symptoms, recorded with a questionnaire
timeFrame: through study completion, an average of 2 years
measure: The change in satisfaction score
timeFrame: through study completion, an average of 2 years
measure: Adverse Events (AEs).
timeFrame: month 24
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sarah Thomis, PhD
role: PRINCIPAL_INVESTIGATOR
References: