Outcomes of Different Treatment Options in Chronic Venous Disease

Chronic Venous Disease Clinical Trial

— VOS  

Official title:

An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06318988
• Other study ID #: S67030
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: December 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Sarah THOMIS, PhD
• Phone: +32498296629
• Email: sarah.thomis[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: May 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Disease

Intervention

Procedure:
• Radiofrequency ablation using Closure fast
Thermal ablation technique
• Aethoxysclerol
sclero-or foamsclerose

Drug:
• Daflon
Venoactive drugs

Device:
• Compression stocking
Compression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Intervention as secondary/add-on treatment	Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment	month 24
Secondary	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	through study completion, an average of 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs).	Number and proportion of patients with Adverse Events (AEs).	month 24