NCT01368159

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Le Club Mousse · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Not desired

Conditions

• Venous Disease

Interventions

Type	Name	Description
DEVICE	Compression 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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-06-07
• Last updated: 2011-09-14