CClinicalTrials.gg
CompletedNCT01368159Updated Sep 14, 2011

Efficacy on Pain Following a Procedure for Injecting Sclerotherapeutic Foam Into the Great Saphenous Vein

A Phase 4 interventional study of Compression Stockings in Venous Disease, sponsored by Le Club Mousse. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-14.

Sponsored by Le Club Mousse · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

Read the detailed description

Not desired

02

Conditions studied

  • Venous Disease
03

In context

Lead sponsor

This is the only study on the registry with Le Club Mousse as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    pressure centred at 25 mm Hg

    Device: Compression Stockings

  • Active comparator
    pressure between 20 and 36 mm Hg

    Device: Compression Stockings

  • Placebo comparator
    pressure between 10 and 15 mm Hg

    Device: Compression Stockings

Interventions

  • DeviceCompression Stockings

    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.

    Also known as: ACTYS 25 ®, Varisma Comfort Coton ®, Varisma Séduction ®

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 25 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01368159
Lead sponsor
Le Club Mousse
Responsible party
Sponsor
First posted
Jun 7, 2011
Start date
Nov 2010
Primary completion
May 2011
Completion
May 2011
Last update
Sep 14, 2011

Study contacts

Charles ZARCA, MD
principal investigator · Le Club Mousse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion