Using Venostan to Reduce Swelling After Ankle Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Venostan, a horse chestnut seed extract, in reducing postoperative swelling in patients with ankle fractures undergoing internal fixation surgery. Eligible participants will be randomly assigned to receive either Venostan or standard treatment following their surgery. The study will assess changes in ankle circumference, range of motion, and any adverse events during follow-up. Data will be collected from multiple hospitals to ensure a diverse patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Jishuitan Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Ting Li
• Email: liting2000@sina.com
• Phone: 86-010-58517207

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.