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

NCT01368159 | Completed Phase 4

• 1 other identifier: Classmousse1
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Venous Disease

Outcome Measures

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

  25 days

Study Arms (3)

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

Interventions

Compression Stockings DEVICE

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 ®

pressure between 10 and 15 mm Hg; pressure between 20 and 36 mm Hg; pressure centred at 25 mm Hg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• Patient at least 18 years old
• Patient agreeing to give her informed consent in writing
• Patient registered with the social security or equivalent regime;
• Linked to the pathology:
• 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).

You may not qualify if:

• 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.
• 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 suffering from arteriopathy of the lower limbs with a systolic pressure index at the ankle of \< 0.6
• Open ulcer in the LL (C6 of CEAP classification).

Sponsors & Collaborators

• Le Club Mousse: lead

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Charles ZARCA, MD

  Le Club Mousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: June 7, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09