Chronic Venous DiseaseVOSNCT06318988
Outcomes of Different Treatment Options in Chronic Venous Disease
An observational study of Chronic Venous Disease, run by Universitaire Ziekenhuizen KU Leuven.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease
- What is being tested?
- Radiofrequency ablation using Closure fast, Aethoxysclerol and Daflon
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from chronic venous disease who did not receive any dedicated treatment for CVD 3 months prior to inclusion
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Radiofrequency ablation using Closure fast, Aethoxysclerol, Daflon, Compression stocking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation using Closure fastProcedure or surgery
Also called Laserablation using laser fiber
Thermal ablation technique
AethoxysclerolProcedure or surgery
Also called polidocanol
sclero-or foamsclerose
DaflonDrug
Also called Venoruton, Antistax
Venoactive drugs
Compression stockingDevice
Compression
| Study group | Role | What they receive |
|---|---|---|
| conservative | compression therapy, and oral or topical venoactive drugs Receives: Drug: Daflon; Device: Compression stocking | |
| invasive | sclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation Receives: Procedure: Radiofrequency ablation using Closure fast; Procedure: Aethoxysclerol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 12 weeks
Secondary outcomes (7)
Intervention as secondary/add-on treatment
Proportion of patients who received an intervention as secondary/add-on treatment to conservative treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 2 years
Adverse Events (AEs).
Number and proportion of patients with Adverse Events (AEs).
Measured: month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Thomis, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318988
- Sponsor's protocol ID
- S67030
- Acronym
- VOS
- Status last verified
- Jun 2024
- First submitted
- 29 Feb 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Study to Assess the Outcomes of Different Treatment Options in Patients With Chronic Venous Disease in Belgium
- ClinicalTrials.gov ID
- NCT06318988
- Acronym / sponsor ID
- VOS / S67030
- Conditions
- Chronic Venous Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative | – | Drug: Daflon, Device: Compression stockingcompression therapy, and oral or topical venoactive drugs |
| invasive | – | Procedure: Radiofrequency ablation using Closure fast, Procedure: Aethoxysclerolsclerotherapy, foamsclerotherapy, open surgery, endovenous thermal ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from chronic venous disease who did not receive any dedicated treatment for CVD 3 months prior to inclusion
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation using Closure fastAlso: Laserablation using laser fiberThermal ablation technique | Procedure or surgery | invasive |
| AethoxysclerolAlso: polidocanolsclero-or foamsclerose | Procedure or surgery | invasive |
| DaflonAlso: Venoruton, AntistaxVenoactive drugs | Drug | conservative |
| Compression stockingCompression | Device | conservative |
Primary outcome
Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score
Time frame: baseline to 12 weeks
Chronic Venous Insufficiency QOL questionnaire-20 score, min 20 max 100, higher means worse outcome
7 secondary outcomes
Intervention as secondary/add-on treatment
Time frame: month 24
The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20)
Time frame: through study completion, an average of 2 years
The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification)
Time frame: through study completion, an average of 2 years
The change in the revised Venous Clinical Severity Score (rVCSS)
Time frame: through study completion, an average of 2 years
The change in the symptoms, recorded with a questionnaire
Time frame: through study completion, an average of 2 years
The change in satisfaction score
Time frame: through study completion, an average of 2 years
Adverse Events (AEs).
Time frame: month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Thomis, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Disease, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah THOMIS, PhD (+32498296629, sarah.thomis@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score (time frame: baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.