Compression Stockings in Ankle Sprain
CASED
Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
1 other identifier
interventional
130
1 country
1
Brief Summary
This is a multicenter prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain and testing the hypothesis that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 31, 2012
June 1, 2010
2.5 years
September 23, 2010
July 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delay to recovery of normal painless walking, without any analgesic drug consumption.
up to 90 days
Secondary Outcomes (7)
Pain at rest using a visual analog pain scale
at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Bimalleolar perimeter
at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Number of days with analgesic drug consumption
at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Observance analysis
at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Delay to recover sport activities in the subgroup of patients having a regular sport activity
at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)
- +2 more secondary outcomes
Study Arms (2)
compression stockings
EXPERIMENTALstandard non compressive stockings
PLACEBO COMPARATORInterventions
standard non compressive stockings
Eligibility Criteria
You may qualify if:
- Recent (\<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years.
You may not qualify if:
- Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Pierre and Marie Curie Universitycollaborator
- Poitiers University Hospitalcollaborator
Study Sites (1)
Pitié Salpetriere hospital
Paris, 75013, France
Related Publications (1)
Bendahou M, Khiami F, Saidi K, Blanchard C, Scepi M, Riou B, Besch S, Hausfater P. Compression stockings in ankle sprain: a multicenter randomized study. Am J Emerg Med. 2014 Sep;32(9):1005-10. doi: 10.1016/j.ajem.2014.05.054. Epub 2014 Jun 12.
PMID: 25043629DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Hausfater, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2010
First Posted
December 14, 2010
Study Start
January 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 31, 2012
Record last verified: 2010-06