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NCT06189625: PED_HUIL1223
Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
NA trial testing Control in Mild Ankle Sprain in 113 participants. Completed in 18 May 2022.
18 May 2022
Quick facts
| Lead sponsor | Hospital Universitario Infanta Leonor |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 113 |
| Start date | 1 September 2021 |
| Primary completion | 18 May 2022 |
| Estimated completion | 18 May 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Control
- Functional bandage
Conditions studied
- Mild Ankle Sprain — all drugs for Mild Ankle Sprain →
Sponsor
Hospital Universitario Infanta Leonor
Who can join
Adults 5 to 16, any sex, with Mild Ankle Sprain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ankle sprains represent a prevalent pathology among the pediatric population that can result in residual effects when treated incorrectly. However, there is a lack of scientific studies defining the most appropriate therapeutic approach. Our hypothesis is that patients treated solely with general measures, without external device support, experience a faster recovery compared to those treated with ankle immobilization. A clinical trial will be carried out by randomly assigning patients to either the functional bandaging group or the control group (general measures only). Prospective follow-up will be carried out by telephone, checking the functionality of the injured ankle using 'the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)', in addition to pain control and patient satisfaction with the treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Non-restraint in pediatric ankle sprain: a non-inferiority randomized clinical trial.
Suarez-Cabezas S, Perez-Moneo B, Cabrerizo Ortiz M, Hortigüela Aparicio M, et al · · 2024 · PMID 39644340 · DOI 10.1007/s00431-024-05904-w -
Non-restraint in pediatric ankle sprain: A non-inferiority randomized clinical trial.
Suarez-Cabezas S, Perez-Moneo B, Ortiz MC, Aparicio MH, et al · · 2024 · DOI 10.21203/rs.3.rs-4717190/v1
Verify or expand the search:
- PubMed search for NCT06189625
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06189625 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario Infanta Leonor
- Last refreshed: 17 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06189625.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing