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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Venous Disease
• Intervention / Treatment: Drug: Daflon; Device: Compression stocking; Procedure: Radiofrequency ablation using Closure fast; Procedure: Aethoxysclerol

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Sarah THOMIS, PhD; Phone Number: +32498296629; Email: sarah.thomis@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
conservative; compression therapy, and oral or topical venoactive drugs	Drug: Daflon; Venoactive drugs; Other Names: Venoruton; Antistax; Device: Compression stocking; Compression
invasive; sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation	Procedure: Radiofrequency ablation using Closure fast; Thermal ablation technique; Other Names: Laserablation using laser fiber; Procedure: Aethoxysclerol; sclero-or foamsclerose; Other Names: polidocanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Sarah Thomis, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol
• Other Study ID Numbers: S67030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No