Chronic Venous DiseaseVEIN STEPNCT04574375
Chronic VEnous dIsorders maNagement and Treatment effectivenesS evaluaTion in Chronic vEnous Disease, an International Program
An observational study of Chronic Venous Disease, run by Servier Affaires Médicales at 1 site in France.
Trial summary
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease
- How many people
- 6,419 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment
Who may be able to join
- Age ≥18 years old
- Patient consulting spontaneously or referred for symptomatic venous disorders
- Diagnosis of chronic venous disease according to investigator's judgment
Who cannot join
- Presence of known severe systemic disease likely to interfere with the study evaluation
- Patients with lower limb arterial disease
- Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema
- Patient consulting for an emergency not related to venous disease
- Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery
- Procedure or surgery for venous disease planned during the study
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD
- Conditions
- Chronic Venous Disease
- Keywords
- observationnal, QoL
What is being measured
The primary outcome is the main question the study is designed to answer.
Global leg symptoms severity
Measured by visual analogue scale (VAS) and questioning with 4 points rate
Measured: week 4
Global improvement
Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.
Measured: Week 4
Disease severity
Measured by VCSS (Venous Clinical Severity score)
Measured: Week 4
Quality of Life
Measured by CIVIQ-14 questionnaire
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Jun 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- 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
- 6,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Affaires Médicales
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574375
- Sponsor's protocol ID
- DIM-05682-007-INT
- Acronym
- VEIN STEP
- Status last verified
- Dec 2022
- First submitted
- 15 Sep 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mezalek ZT, Feodor T, Chernukha L, Chen Z, Rueda A, Sanchez IE, Ochoa AJG, Chirol J, Blanc-Guillemaud V, Lohier-Durel C, Ulloa JH. VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease. Adv Ther. 2023 Nov;40(11):5016-5036. doi: 10.1007/s12325-023-02643-6. Epub 2023 Sep 20.
PubMed 37728696
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease
- ClinicalTrials.gov ID
- NCT04574375
- Acronym / sponsor ID
- VEIN STEP / DIM-05682-007-INT
- Conditions
- Chronic Venous Disease
- Keywords
- observationnal, QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,419 participants (actual)
- Lead sponsor
- Servier Affaires MédicalesIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Oct 2020 (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.
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Patient consulting spontaneously or referred for symptomatic venous disorders
- Diagnosis of chronic venous disease according to investigator's judgment
Key exclusion criteria (7 listed)
- Presence of known severe systemic disease likely to interfere with the study evaluation
- Patients with lower limb arterial disease
- Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema
- Patient consulting for an emergency not related to venous disease
- Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global leg symptoms severity
Time frame: week 4
Measured by visual analogue scale (VAS) and questioning with 4 points rate
Global improvement
Time frame: Week 4
Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.
Disease severity
Time frame: Week 4
Measured by VCSS (Venous Clinical Severity score)
Quality of Life
Time frame: Week 4
Measured by CIVIQ-14 questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 37728696Mezalek ZT, Feodor T, Chernukha L, Chen Z, Rueda A, Sanchez IE, Ochoa AJG, Chirol J, Blanc-Guillemaud V, Lohier-Durel C, Ulloa JH. VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease. Adv Ther. 2023 Nov;40(11):5016-5036. doi: 10.1007/s12325-023-02643-6. Epub 2023 Sep 20.
- VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease (in Advances in Therapy, September 2023)Link provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Disease, run by Servier Affaires Médicales at 1 site in France.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global leg symptoms severity (time frame: week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574375, which also lists 1 linked publication.
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 6 Oct 2023.