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
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
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.
General:
Linked to the pathology:
Exclusion Criteria:
Linked to the pathology/product:
Device: Compression Stockings
Device: Compression Stockings
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.
Also known as: ACTYS 25 ®, Varisma Comfort Coton ®, Varisma Séduction ®
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
No study locations are listed for this record.
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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