NCT06657937

Brief Summary

To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 28, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

October 23, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

EmergencyHealingAnkleSprain

Outcome Measures

Primary Outcomes (1)

  • To evaluate the recovery experienced by patients with ankle sprains treated in the adult emergency department of Nantes University Hospital.

    Percentage of patients feeling fully cured at D30

    30 days

Secondary Outcomes (8)

  • Compare healing sensation with different types of immobilization

    30 days

  • Compare healing sensation with duration of immobilization

    30 days

  • Compare the feeling of healing with the initial analgesic proposed

    30 days

  • Comparing the feeling of recovery according to whether or not a state-certified physiotherapist was involved in the treatment

    30 days

  • Compare the feeling of recovery according to the presence or absence of early medical reassessment

    30 days

  • +3 more secondary outcomes

Study Arms (1)

Study population

The study population must correspond to the research inclusion criteria: Adult patients admitted to the emergency department, presenting with an ankle sprain

Other: Questionnaire

Interventions

An initial questionnaire is completed on D0, the day of the patient's admission to the emergency department, by the practitioner in charge of the patient, and covers the patient's anamnesis, clinical examination, radiological examinations and treatment. A follow-up telephone visit is then carried out at 30 days by an investigator, to gather information on the clinical and therapeutic evolution, and to evaluate the recovery and evolution of symptoms experienced by the patient in relation to the initial management.

Also known as: Phone call
Study population

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of patients admitted to adult emergency departments with ankle sprains.

You may qualify if:

  • Patient over 18 years of age
  • Presenting an isolated ankle sprain
  • Visiting Nantes CHU emergency department for this reason
  • Patient able to read and speak French
  • Patient covered by a social security scheme

You may not qualify if:

  • Patient \> 70 years old
  • Patients requiring hospitalization following a visit to the emergency department
  • Any intercurrent pathology that may affect the management of the ankle sprain
  • Associated ankle fracture
  • Patients under legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44000, France

Location

MeSH Terms

Conditions

Ankle InjuriesEmergenciesSprains and Strains

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 26, 2024

Study Start

November 28, 2024

Primary Completion

May 7, 2025

Study Completion

June 6, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations