Ankle SprainPFEECNCT06856889
Systematic Ultrasound in the Initial Assessment of Ankle Sprain
An observational study of Ankle Sprain, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ankle Sprain
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2025to 2 Dec 2025
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with ankle sprain
Who may be able to join
- Clinical diagnosis of ankle sprain made during a preliminary prior consultation
- Patients undergoing re-evaluation of sprain severity, between D3 and D6 of trauma
Who cannot join
- Medial sprain
- Sprain recurrence <6 months
- Age < 15 years
- Radiographic fracture confirmed on an X-ray performed between initial diagnosis and re-evaluation visit
- History of hyperlaxity syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Value of Systematic Ultrasound in the Initial Assessment of Ankle Sprain on Functional Prognosis at 3 Months in the General Population: Pilot Observational Study (PFEEC)
Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.
- Conditions
- Ankle Sprain
- Keywords
- ultrasound scan
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | no ultrasound scan | |
| Experimental groupe | ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of systematic ultrasound in the initial assessment of ankle sprains on patients' quality of life and sporting activities at 3 months post-injury trauma.
Comparison of ankle-specific quality of life in terms of activities of daily living and sporting activities. This criterion will be measured using the FAAM (Foot and Ankle Ability Measure), a specific questionnaire functional evaluation of the ankle in these activities.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start7 Mar 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856889
- Sponsor's protocol ID
- 2024-12-PFEEC
- Acronym
- PFEEC
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of Systematic Ultrasound in the Initial Assessment of Ankle Sprain on Functional Prognosis at 3 Months in the General Population: Pilot Observational Study (PFEEC)
- ClinicalTrials.gov ID
- NCT06856889
- Acronym / sponsor ID
- PFEEC / 2024-12-PFEEC
- Conditions
- Ankle Sprain
- Keywords
- ultrasound scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- 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.
Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –no ultrasound scan |
| Experimental groupe | – | –ultrasound scan |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with ankle sprain
Key inclusion criteria (2 listed)
- Clinical diagnosis of ankle sprain made during a preliminary prior consultation
- Patients undergoing re-evaluation of sprain severity, between D3 and D6 of trauma
Key exclusion criteria (5 listed)
- Medial sprain
- Sprain recurrence <6 months
- Age < 15 years
- Radiographic fracture confirmed on an X-ray performed between initial diagnosis and re-evaluation visit
- History of hyperlaxity syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Value of systematic ultrasound in the initial assessment of ankle sprains on patients' quality of life and sporting activities at 3 months post-injury trauma.
Time frame: 3 months
Comparison of ankle-specific quality of life in terms of activities of daily living and sporting activities. This criterion will be measured using the FAAM (Foot and Ankle Ability Measure), a specific questionnaire functional evaluation of the ankle in these activities.
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 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprain
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprain, run by Hopital Nord Franche-Comte 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 2 inclusion and 5 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 25 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Value of systematic ultrasound in the initial assessment of ankle sprains on patients' quality of life and sporting activities at 3 months post-injury trauma. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.