Venous DiseasePhase 4NCT01368159
Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the Great Saphenous Vein
A Phase 4 study testing Compression Stockings in people with Venous Disease, run by Le Club Mousse.
Trial summary
The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Venous Disease
- What is being tested?
- Compression Stockings
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to May 2011
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General:
- Patient at least 18 years old
- Patient agreeing to give her informed consent in writing
- Patient taking effective contraceptive on inclusion and not planning pregnancy during the trial period.
- Patient registered with the social security or equivalent regime;
- Linked to the pathology:
- Patient suffering from truncal insufficiency of the SVG supplied either by reflux from the saphenofemoral junction, with or without competent terminal valve, or by collaterals or perineal varicosities in the subinguinal region and who is scheduled to have endovenous injection of sclerotherapeutic foam into the great saphenous vein presenting truncal reflux of at least one second, the diameter of which is at least 4 mm (no limit for maximum calibre) standing 15 cm from the inguinal fold (according to an echo-doppler taken less than three months prior to inclusion).
- Injection initially planned of 2% Aetoxisclerol, the injection volume of which is limited to 3 ml of liquid, i.e. less than 15 ml of foam, for complete filling of the great saphenous and a spasm. (to standardise the procedure before fitting the compression hose) Patient classified C2 to C5 (clinical stages in CEAP classification).
Who cannot join
- General:
- Patient regularly taking analgesics or anti-inflammatories.
- Patient suffering from a state or prior history of mental or psychiatric disorder or any other factor limiting aptitude to take an informed part and respect of the protocol; Patient suffering from chronic hepatopathology.
- Renal insufficiency (clearance < 60 ml/min. according to Cockcroft).
- Patient suffering from a known evolving malignant pathology.
- Patient suffering from decompensated cardiac or respiratory insufficiency.
Show all 19Show fewer
- Patient who is pregnant or breast-feeding.
- Patient currently taking part in a clinical trial or who took part in a clinical trial during the month preceding inclusion.
- Person deprived of liberty by a legal or administrative decision, Adult patient protected by the law, under legal protection or guardianship.
- Linked to the pathology/product:
- Patient suffering from LL pain other than vascular (sciatica, gonarthrosis, neuropathy, etc.)
- Patient presenting contraindications for class III venous compression (20 to 36 mmHg)
- Patient with a prior history of skin reactions following the use of venous compression products
- Scheduling a procedure for endovenous injection other than into the great saphenous vein during the period of study of the leg, planned during the 2 months following SVG sclerosis.
- Patient displaying post-thrombotic or primary anomalies of the deep vein network on the Echo-Doppler (less than 3 months before inclusion).
- Patient suffering from arteriopathy of the lower limbs with a systolic pressure index at the ankle of < 0.6
- Saphenous incompetence not meeting the anatomical and/or haemodynamic criteria defined in the inclusion criteria.
- Open ulcer in the LL (C6 of CEAP classification).
- Patient not tolerating compression or requiring chronic fitting of high pressure compression (in excess of 20 mmHg).
About this study
Official title: Randomised, Comparative Trial in Parallel Groups and Blinded, to Compare Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the G.S V. Under Echography Control, Between Three Types of Medical Compression Hose
The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The "Class I compression" versus "The two class III compressions" contrast will also be studied.
Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the morning and evaluated by the patient at the end of the day.
Read more
Consumption of analgesics or the number of days of analgesic treatment necessary for the 3 compression types used will be compared.
One of the trial objectives is also to show that regular use of a class III compression product leads to a reduction in complications following sclerosis (by reducing the number of non-serious/serious complications specific to sclerosis: matting, pigmentation, inflammation, development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.). The trial also aims to compare the rate of successful sclerosis between the three devices, success being defined by complete or partial occlusion of the great saphenous vein, leading to the disappearance of reflux at the crural level.
The other secondary objectives will be patient evaluation of comfort, ease of putting on and taking off the compression hose and a global appreciation of the procedure for echoguided endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by wearing compression hose.
Read the detailed description
Not desired
- Conditions
- Venous Disease
- Being tested
- Compression Stockings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression StockingsDevice
Also called ACTYS 25 ®, Varisma Comfort Coton ®, Varisma Séduction ®
The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The "Class I compression" versus "The two class III compressions" contrast will also be studied.
| Study group | Role | What they receive |
|---|---|---|
| pressure centred at 25 mm Hg | Active comparator | Not described Receives: Device: Compression Stockings |
| pressure between 20 and 36 mm Hg | Active comparator | Not described Receives: Device: Compression Stockings |
| pressure between 10 and 15 mm Hg | Placebo comparator | Not described Receives: Device: Compression Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain following a procedure for injecting sclerotherapeutic foam into the Great Saphenous vein under echography control
Pain evaluated from D1 to D21 by the patient at the end of the day using a vertical visual analog scale (VAS) on 10 cm not fixed, in the patient's book: "Indicate the maximum intensity of your pain along the route of the treated vein since this morning and before taking any analgesic. Draw a horizontal line on the vertical line below
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Club Mousse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles ZARCA, MD, Principal investigator, Le Club Mousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368159
- Sponsor's protocol ID
- Classmousse1
- Status last verified
- Sep 2011
- First submitted
- 13 Apr 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Comparative Trial in Parallel Groups and Blinded, to Compare Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the G.S V. Under Echography Control, Between Three Types of Medical Compression Hose
- ClinicalTrials.gov ID
- NCT01368159
- Acronym / sponsor ID
- Classmousse1
- Conditions
- Venous Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Le Club MousseUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jun 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.
The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The "Class I compression" versus "The two class III compressions" contrast will also be studied.
Efficacy will be measured by totalling the VAS scores for maximum pain experienced since the morning and evaluated by the patient at the end of the day.
Consumption of analgesics or the number of days of analgesic treatment necessary for the 3 compression types used will be compared.
One of the trial objectives is also to show that regular use of a class III compression product leads to a reduction in complications following sclerosis (by reducing the number of non-serious/serious complications specific to sclerosis: matting, pigmentation, inflammation, development of sclerosis requiring drainage, DVT, pulmonary embolism, etc.). The trial also aims to compare the rate of successful sclerosis between the three devices, success being defined by complete or partial occlusion of the great saphenous vein, leading to the disappearance of reflux at the crural level.
The other secondary objectives will be patient evaluation of comfort, ease of putting on and taking off the compression hose and a global appreciation of the procedure for echoguided endovenous injection of sclerotherapeutic foam into the great saphenous vein, followed by wearing compression hose.
Detailed description
Not desired
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pressure centred at 25 mm Hg | Active comparator | Device: Compression Stockings |
| pressure between 20 and 36 mm Hg | Active comparator | Device: Compression Stockings |
| pressure between 10 and 15 mm Hg | Placebo comparator | Device: Compression Stockings |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient at least 18 years old
- Patient agreeing to give her informed consent in writing
- Patient taking effective contraceptive on inclusion and not planning pregnancy during the trial period.
- Patient registered with the social security or equivalent regime;
- Patient suffering from truncal insufficiency of the SVG supplied either by reflux from the saphenofemoral junction, with or without competent terminal valve, or by collaterals or perineal varicosities in the subinguinal region and who is scheduled to have endovenous injection of sclerotherapeutic foam into the great saphenous vein presenting truncal reflux of at least one second, the diameter of which is at least 4 mm (no limit for maximum calibre) standing 15 cm from the inguinal fold (according to an echo-doppler taken less than three months prior to inclusion).
Key exclusion criteria (19 listed)
- General:
- Patient regularly taking analgesics or anti-inflammatories.
- Patient suffering from a state or prior history of mental or psychiatric disorder or any other factor limiting aptitude to take an informed part and respect of the protocol; Patient suffering from chronic hepatopathology.
- Renal insufficiency (clearance < 60 ml/min. according to Cockcroft).
- Patient suffering from a known evolving malignant pathology.
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 |
|---|---|---|
| Compression StockingsAlso: ACTYS 25 ®, Varisma Comfort Coton ®, Varisma Séduction ®The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The "Class I compression" versus "The two class III compressions" contrast will also be studied. | Device | pressure between 10 and 15 mm Hg, pressure between 20 and 36 mm Hg, pressure centred at 25 mm Hg |
Primary outcome
pain following a procedure for injecting sclerotherapeutic foam into the Great Saphenous vein under echography control
Time frame: 25 days
Pain evaluated from D1 to D21 by the patient at the end of the day using a vertical visual analog scale (VAS) on 10 cm not fixed, in the patient's book: "Indicate the maximum intensity of your pain along the route of the treated vein since this morning and before taking any analgesic. Draw a horizontal line on the vertical line below
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 14 Sep 2011.
Related trials for Venous Disease
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingPhase 4
Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias
Telangiectasias, Reticular Veins
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
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.
Charles ZARCA, MD principal investigator
Le Club Mousse
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compression Stockings in people with Venous Disease, run by Le Club Mousse.
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 8 inclusion and 19 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 14 Sep 2011. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pain following a procedure for injecting sclerotherapeutic foam into the Great Saphenous vein under echography control (time frame: 25 days). 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 14 Sep 2011.