NCT07405281

Brief Summary

Investigators recruited 208 patients with acute ankle sprain who were from the Rehabilitation Department of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2026 to November 2028. Perform the improvement in AOFAS scores and Baird-Jackson ankle scores study and Rehabilitation assessments followed up after 3 years.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

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

Study Progress10%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

January 20, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 20, 2026

Last Update Submit

February 11, 2026

Conditions

Ankle Sprain

Keywords

acute ankle sprainhyperbaric oxygen

Outcome Measures

Primary Outcomes (2)

  • AOFAS score

    Improvement of American Orthopaedic Foot \& Ankle Society Score （AOFAS scores）in acute ankle sprains with early HBO treatment. Usually scored from 0 to 100, higher scores mean a better outcome.

    3 years

  • Baird-Jackson ankle score

    Improvement of Baird-Jackson Ankle Evaluation Score（Baird-Jackson ankle scores） in acute ankle sprains with early HBO treatment. Usually scored from 0 to 100., higher scores mean a better outcome.

    3 years

Secondary Outcomes (6)

  • pain scores

    3 years

  • ankle swelling

    3 years

  • high-frequency ultrasound findings

    3 years

  • Ankle MRI

    3 years

  • patient's overall evaluation of treatment (PGIC)

    3 years

  • +1 more secondary outcomes

Study Arms (2)

hyperbaric oxygen group

EXPERIMENTAL

The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation.

Other: hyperbaric oxygen therapy

non hyperbaric oxygen group

SHAM COMPARATOR

The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%

Other: non Hyperbaric Oxygen Therapy

Interventions

hyperbaric oxygen therapyOTHER

The treatment is administered at an atmospheric pressure of 2 ATA, with 100% oxygen inhalation. Oxygen inhalation time: 40 minutes (inhaling oxygen for 20 minutes, resting for 5 minutes, inhaling oxygen for 20 minutes, decompression), once daily, for 14 consecutive days. (Commenced immediately after randomisation)

hyperbaric oxygen group
non Hyperbaric Oxygen TherapyOTHER

The treatment is administered at an atmospheric pressure of 1.4 ATA with an inhaled oxygen fraction of 21%, oxygen inhalation time: 40 minutes (20 minutes of oxygen inhalation, 5 minutes rest, 20 minutes of oxygen inhalation, decompression), once daily, for 14 consecutive days. (Commences immediately after randomisation)

non hyperbaric oxygen group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral ankle sprain;
  • Swelling, bruising, and pain at the site of the sprain;
  • Injury occurring within 72 hours;
  • MRI examination clearly shows ligament damage.

You may not qualify if:

  • X-ray shows ankle fracture;
  • Ankle has skin lesions or skin diseases;
  • History of lower limb and pelvic surgery;
  • Obvious neurological or psychiatric disorders that may interfere with assessment;
  • Severe ligament injuries or joint instability requiring surgical treatment;
  • Previous ankle injuries, persistent pain or functional limitations;
  • Pneumothorax, severe emphysema, active bleeding, or other diseases with contraindications for hyperbaric oxygen therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Bing Xiong

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xiong, MD

CONTACT

86-135168031562202030@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

February 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share