RecruitingNot Applicable

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

China290 participantsStarted 2025-04-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in ankle circumference at 6 days postoperatively compared to baseline

Timeframe: from enrollment to the 6th day postoperation

Trial details

NCT IDNCT06872034

SponsorBeijing Jishuitan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-12

Contact for this trial

Ting Li

86-010-58517207 liting2000@sina.com

View on ClinicalTrials.gov More Swelling/ Edema trials