The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Jishuitan Hospital

About this trial

This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. General and disease-related data will be collected. All eligible patients must voluntarily sign an informed consent form after understanding and accepting the study. Successfully recruited participants will undergo internal fixation surgery at a scheduled time and then be randomly assigned to either the Venostan (horse chestnut seed extract tablet) group or the conventional treatment group. They will receive the corresponding treatments according to the study protocol. Follow-up assessments will include changes in ankle circumference, ankle range of motion, scale evaluation results, laboratory test results, and adverse events. The study aims to evaluate the effects of Venostasin in patients with ankle fractures undergoing internal fixation surgery, exploring its potential to promote postoperative reduction of ankle swelling, enhance early joint function recovery, and investigate its safety in postoperative fracture management.

Eligibility criteria

Qualifiers

≥18 year old, no gender restriction;

Diagnosed with ankle fracture confirmed by imaging data, AO classification: ---AO-43, AO-44-F3, AO-44;

Scheduled to undergo open reduction and internal fixation surgery;

Voluntary signing of the informed consent form.

Disqualifiers

Pregnant or lactating women;

With contraindications to surgery;

With other severe combined injuries or soft tissue infections;

Severe multiple trauma: Injury Severity Score (ISS) > 16;

Trial design

Treatments tested in this trial

  • Venostasin (horse chestnut seed extract tablets)
  • standard treatment

Treatment groups

290 Participants
are divided into 2 treatment groups

Sponsors and collaborators