Chronic Venous Insufficiency (CVI)Phase 3NCT01402921
Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema
A Phase 3 study testing V0322 BC in people with Chronic Venous Insufficiency (CVI), run by Pierre Fabre Medicament at 1 site in France.
Trial summary
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency (CVI)
- What is being tested?
- V0322 BC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Mar 2012
- Phase
- Phase 3
- 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
Who may be able to join
- Age 18 years and above
- Permanent chronic oedema of venous origin (C3 based on CEAP classification) confirmed by Doppler or Duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins
- Pitting oedema
- Have given and signed written informed consent
- Registered with or benefiting from health insurance (Mandatory for France)
Who cannot join
- Use of compression therapy in the last 5 days before inclusion
- Common contraindications for MCT (arteriopathy, decompensated heart failure, infectious dermatitis
- Isolated lipoedema
- Isolated lymphoedema (Kaposi- Stemmer sign
- Severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia …)
- Known hypersensitivity to any component of MCT
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- Important limitation of ankle movement requiring a specific therapy
- Following treatment initiated or dose-modified 1 month prior to inclusion: NSAID, corticosteroids, calcium blockers, ACE inhibitors, Angiotensin II inhibitors, vasoconstrictors or vasodilators
- Hormonal treatment initiated or dose-modified 1 month prior to inclusion
- Diuretic and/or phlebotonic treatment initiated or dose-modified 1 month prior to inclusion
- Pregnancy, breast feeding, planning to become pregnant, or not using any form of contraception
- Patient linguistically or psychologically unable to understand the information given or who refuses to give his/her consent in writing
- Participation in another clinical trial
- Deprived of liberty for administrative, medical and legal reasons
- May not be compliant with the constraints imposed by the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).
The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.
- Conditions
- Chronic Venous Insufficiency (CVI)
- Being tested
- V0322 BC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0322 BCDevice
- Stocking Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004).
- The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg)
- 3 months duration daily treatment
| Study group | Role | What they receive |
|---|---|---|
| Elastic Medical Compressive Therapy | Experimental | V0322BC verum medical compressive therapy is a progressive compressive sock with:
* ankle pressure: 10 mmHg
* calf pressure : 23 mmHg Receives: Device: V0322 BC |
| Placebo | Placebo comparator | V0322BC placebo medical compressive therapy is a progressive compressive sock with:
* ankle pressure: <5 mmHg
* calf pressure : <7 mmHg Receives: Device: V0322 BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)
The main criterion is defined as the target leg volume reduction of chronic venous oedema measured by volumetry method with water displacement at 3 months
Measured: Day 90
Secondary outcomes (5)
Functional symptoms by VAS (pain, heaviness) at each visit by the patient.
Measured: 0-Day 7-Day 30 and Day 90
Quality of life. SQOR-V and ABC-V (FARDEAU) score
Measured: 0-Day 7-Day 30 and Day 90
Body weight variation
Measured: 0-Day 7-Day 30 and Day 90
Suprafacial Thickness Measured Duplex measurement
Measured: 0-Day 7-Day 30 and Day 90
Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)
Measured: Day 7-Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency (CVI)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402921
- Sponsor's protocol ID
- V00322 BC 402
- Status last verified
- Nov 2016
- First submitted
- 13 Jul 2011
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo
- ClinicalTrials.gov ID
- NCT01402921
- Acronym / sponsor ID
- V00322 BC 402
- Conditions
- Chronic Venous Insufficiency (CVI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jul 2011 (estimated)
- 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.
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).
The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic Medical Compressive Therapy | Experimental | Device: V0322 BCV0322BC verum medical compressive therapy is a progressive compressive sock with: * ankle pressure: 10 mmHg * calf pressure : 23 mmHg |
| Placebo | Placebo comparator | Device: V0322 BCV0322BC placebo medical compressive therapy is a progressive compressive sock with: * ankle pressure: <5 mmHg * calf pressure : <7 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and above
- Permanent chronic oedema of venous origin (C3 based on CEAP classification) confirmed by Doppler or Duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins
- Pitting oedema
- Have given and signed written informed consent
- Registered with or benefiting from health insurance (Mandatory for France)
Key exclusion criteria (15 listed)
- Use of compression therapy in the last 5 days before inclusion
- Common contraindications for MCT (arteriopathy, decompensated heart failure, infectious dermatitis
- Isolated lipoedema
- Isolated lymphoedema (Kaposi- Stemmer sign
- Severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia …)
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 |
|---|---|---|
| V0322 BC* Stocking Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). * The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg) * 3 months duration daily treatment | Device | Elastic Medical Compressive Therapy, Placebo |
Primary outcome
Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement)
Time frame: Day 90
The main criterion is defined as the target leg volume reduction of chronic venous oedema measured by volumetry method with water displacement at 3 months
5 secondary outcomes
Functional symptoms by VAS (pain, heaviness) at each visit by the patient.
Time frame: 0-Day 7-Day 30 and Day 90
Quality of life. SQOR-V and ABC-V (FARDEAU) score
Time frame: 0-Day 7-Day 30 and Day 90
Body weight variation
Time frame: 0-Day 7-Day 30 and Day 90
Suprafacial Thickness Measured Duplex measurement
Time frame: 0-Day 7-Day 30 and Day 90
Assessment of local tolerance (examination of the skin) and safety (general clinical examination and reported adverse events)
Time frame: Day 7-Day 30 and Day 90
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 10 Nov 2016.
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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?
A Phase 3 study testing V0322 BC in people with Chronic Venous Insufficiency (CVI), run by Pierre Fabre Medicament 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 5 inclusion and 15 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 10 Nov 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Volume reduction of the target leg presenting the most important initial volume (by Volumetry using water displacement) (time frame: Day 90). 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 10 Nov 2016.