Outcomes of Different Treatment Options in Chronic Venous Disease

NCT06318988 | Not Yet Recruiting

• 1 other identifier: S67030
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Venous Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intervention as secondary/add-on treatment

  month 24

• The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20)

  through study completion, an average of 2 years

• The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification)

  through study completion, an average of 2 years

• The change in the revised Venous Clinical Severity Score (rVCSS)

  through study completion, an average of 2 years

• The change in the symptoms, recorded with a questionnaire

  through study completion, an average of 2 years

Study Arms (2)

conservative

compression therapy, and oral or topical venoactive drugs

Drug: Daflon; Device: Compression stocking

invasive

sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation

Procedure: Radiofrequency ablation using Closure fast; Procedure: Aethoxysclerol

Interventions

Radiofrequency ablation using Closure fast PROCEDURE

Thermal ablation technique

Also known as: Laserablation using laser fiber

invasive

Aethoxysclerol PROCEDURE

sclero-or foamsclerose

Also known as: polidocanol

invasive

Daflon DRUG

Venoactive drugs

Also known as: Venoruton, Antistax

conservative

Compression stocking DEVICE

Compression

conservative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \* 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.

You may not qualify if:

• 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,
• Patient with any comorbidity or situation preventing a follow-up of 2 years.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Interventions

Polidocanol; Diosmin; troxerutin; Antistax; Stockings, Compression

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Sarah Thomis, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah THOMIS, PhD

CONTACT

+32498296629; sarah.thomis@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 28, 2024

Record last verified: 2024-06