NCT06872034 The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures
| NCT ID | NCT06872034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Jishuitan Hospital |
| Condition | Swelling/ Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2026-01-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2025-04-16 with a primary completion date of 2026-01-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06872034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Swelling/ Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06872034 currently recruiting?
Yes, NCT06872034 is actively recruiting participants. Contact the research team at liting2000@sina.com for enrollment information.
Where is the NCT06872034 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06872034 clinical trial?
NCT06872034 is sponsored by Beijing Jishuitan Hospital. The trial plans to enroll 290 participants.