Compression Stockings in Ankle Sprain

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01259752
• Date of registration: 23/09/2010
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Compression Stockings in Ankle Sprain CASED
• Scientific title: Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
• Date of first enrolment: January 2010
• Target sample size: 130
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01259752
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Pierre Hausfater, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Recent (<48h) ankle sprain without fracture and without other traumatic lesions in
adult patients aged between 18 and 55 years.

Exclusion Criteria:

- Patients with limb arterial disease, diabetes, or any diseases expected to
potentially interfere with recovery of walking, are excluded as well as pregnant
women



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankle Sprain

Intervention(s)

Device: compression stockings

Other: standard non compressive stockings

Primary Outcome(s)

Delay to recovery of normal painless walking, without any analgesic drug consumption. [Time Frame: up to 90 days]

Secondary Outcome(s)

Number of days with analgesic drug consumption [Time Frame: 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 [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)]

middle-feet perimeter [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)]

Observance analysis [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)]

Pain at rest using a visual analog pain scale [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)]

Bimalleolar perimeter [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)]

Pain during walking using a visual analog pain scale [Time Frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)]

Secondary ID(s)

P080603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pierre and Marie Curie University

Poitiers University Hospital