Ankle SprainPhase 3CASEDNCT01259752
Compression Stockings in Ankle Sprain
A Phase 3 study testing compression stockings and standard non compressive stockings in people with Ankle Sprain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- compression stockings and standard non compressive stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years.
Who cannot join
- Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
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.
Read the detailed description
Introduction: Ankle sprain is a frequently encountered trauma lesion in emergency departments and is associated with important health expenses. However, appropriate care of this trauma lesion remains a matter of debate.
Hypothesis: The tested hypothesis is that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days.
Main end point: Delay to recovery of normal painless walking, without any analgesic drug consumption.
Secondary end points : Pain at rest and during walking using a visual analog pain scale, bimalleolar and middle-feet perimeters, number of days with analgesic drug consumption, observance analysis, patient's tolerance using a visual analog scale, delay to recover sport activities in the subgroup of patients having a regular sport activity.
Methods: Multicenter Prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain. Standard care include the RICE (Rest, Ice, Compression, Elevation) protocol at admission, immobilization with ankle bracing (3 to 6 week duration according to severity and clinical course), recommendation for walking (no weight baring, partial weight bearing, total weight bearing), administration of analgesic drugs. The medical device tested in the present study is class II compressive stockings (compression between 15 and 20 mmHg).
Number of patients: With an alpha risk of 5%, a beta risk of 5%, 70 patients should be included in each group to be able to detect a 6 day difference in the delay of recovery, defined as normal painless walking without any analgesic drug consumption, taking into consideration 10% of patients lost during follow up.
Criteria for inclusion: Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years. Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women.
Study schedule: Inclusion during first visit to the emergency department, then at day 7, 15-21, 30-45, and 90. Phone call interviews are performed to define the more appropriate timing of the visits.
- Conditions
- Ankle Sprain
- Being tested
- compression stockings, standard non compressive stockings
- Keywords
- Trauma, ankle sprain, emergency, compression stocking
- Medical subject headings
- Ankle Injuries, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression stockingsDevice
compression stockings
standard non compressive stockingsOther
standard non compressive stockings
| Study group | Role | What they receive |
|---|---|---|
| compression stockings | Experimental | Not described Receives: Device: compression stockings |
| standard non compressive stockings | Placebo comparator | Not described Receives: Other: standard non compressive stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay to recovery of normal painless walking, without any analgesic drug consumption.
Measured: up to 90 days
Secondary outcomes (7)
Pain at rest using a visual analog pain scale
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Bimalleolar perimeter
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Number of days with analgesic drug consumption
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Observance analysis
Number of days actually wearing compression stocking and ankle bracing and taking analgesic drugs
Measured: 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
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45) and at the last follow-up visit (D-90)
Pain during walking using a visual analog pain scale
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
middle-feet perimeter
Measured: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre and Marie Curie University, Poitiers University Hospital
- Responsible party
- Sponsor
- Investigators
- Pierre Hausfater, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259752
- Sponsor's protocol ID
- P080603
- Acronym
- CASED
- Status last verified
- Jun 2010
- First submitted
- 23 Sep 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25043629
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Compression Stockings in Ankle Sprain in Adults
- ClinicalTrials.gov ID
- NCT01259752
- Acronym / sponsor ID
- CASED / P080603
- Conditions
- Ankle Sprain
- Keywords
- Trauma, ankle sprain, emergency, compression stocking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pierre and Marie Curie University, Poitiers University Hospital
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Ankle sprain is a frequently encountered trauma lesion in emergency departments and is associated with important health expenses. However, appropriate care of this trauma lesion remains a matter of debate.
Hypothesis: The tested hypothesis is that compression stockings enable to reduce the median of recovery from ankle sprain by at least 6 days.
Main end point: Delay to recovery of normal painless walking, without any analgesic drug consumption.
Secondary end points : Pain at rest and during walking using a visual analog pain scale, bimalleolar and middle-feet perimeters, number of days with analgesic drug consumption, observance analysis, patient's tolerance using a visual analog scale, delay to recover sport activities in the subgroup of patients having a regular sport activity.
Methods: Multicenter Prospective randomized superiority controlled trial comparing leg stockings and standard care to standard care of ankle sprain. Standard care include the RICE (Rest, Ice, Compression, Elevation) protocol at admission, immobilization with ankle bracing (3 to 6 week duration according to severity and clinical course), recommendation for walking (no weight baring, partial weight bearing, total weight bearing), administration of analgesic drugs. The medical device tested in the present study is class II compressive stockings (compression between 15 and 20 mmHg).
Number of patients: With an alpha risk of 5%, a beta risk of 5%, 70 patients should be included in each group to be able to detect a 6 day difference in the delay of recovery, defined as normal painless walking without any analgesic drug consumption, taking into consideration 10% of patients lost during follow up.
Criteria for inclusion: Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years. Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women.
Study schedule: Inclusion during first visit to the emergency department, then at day 7, 15-21, 30-45, and 90. Phone call interviews are performed to define the more appropriate timing of the visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compression stockings | Experimental | Device: compression stockings |
| standard non compressive stockings | Placebo comparator | Other: standard non compressive stockings |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recent (<48h) ankle sprain without fracture and without other traumatic lesions in adult patients aged between 18 and 55 years.
Key exclusion criteria (1 listed)
- Patients with limb arterial disease, diabetes, or any diseases expected to potentially interfere with recovery of walking, are excluded as well as pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compression stockingscompression stockings | Device | compression stockings |
| standard non compressive stockingsstandard non compressive stockings | Other | standard non compressive stockings |
Primary outcome
Delay to recovery of normal painless walking, without any analgesic drug consumption.
Time frame: up to 90 days
7 secondary outcomes
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)
Number of days with analgesic drug consumption
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)
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)
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)
middle-feet perimeter
Time frame: at each follow-up visit (D-7, D-15 to 21, D-30 to 45)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 25043629Bendahou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Hausfater, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing compression stockings and standard non compressive stockings in people with Ankle Sprain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay to recovery of normal painless walking, without any analgesic drug consumption. (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01259752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.