NCT06318988

Outcomes of Different Treatment Options in Chronic Venous Disease

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Venous Disease

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation using Closure fast	Thermal ablation technique
PROCEDURE	Aethoxysclerol	sclero-or foamsclerose
DRUG	Daflon	Venoactive drugs
DEVICE	Compression stocking	Compression

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2024-03-19
• Last updated: 2024-06-28