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

RecruitingNAAges 18 Years - anyAllBeijing Jishuitan Hospital
NCT06872034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥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. Exclusion Criteria: * 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; * With concurrent fractures of the spine, pelvis, or ipsilateral or contralateral lower limbs; * Pathological fractures; * With peripheral vascular disease or deep vein thrombosis (DVT); * With severe impairment of heart, lung, liver, or kidney function or abnormal coagulation function; * Unable to walk independently before the injury; * With pre-existing lower limb edema (e.g., due to liver cirrhosis, kidney disease, etc.) before the injury; * With mental disorders or hyperalgesia; * Allergic to any component of the investigational drug; * Any contraindications that limit clinical evaluation and treatment of the patient; * Deemed unsuitable for inclusion in this study by the investigator.
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What it tests

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

1 site
Beijing Jishuitan Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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