Venous Disease Clinical Trial
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.
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.
Not desired ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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