Using Venostan to Reduce Swelling After Ankle Surgery

The Efficacy and Safety of Venostan (Horse Chestnut Seed Extract Tablets) in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures: A Multicenter, Open-Label, Randomized Controlled Trial

This study is testing if Venostan, a natural extract, can help reduce swelling after ankle surgery for people with ankle fractures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Jishuitan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06872034 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with specific types of ankle fractures and are scheduled for surgical intervention.

Not a fit: Patients with severe comorbidities, pre-existing lower limb edema, or those unable to walk independently prior to injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce postoperative swelling and improve recovery outcomes for patients with ankle fractures.

How similar studies have performed: While the specific use of Venostan in this context may be novel, similar studies using horse chestnut extract for edema reduction have shown promising results.

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.

Where this trial is running

Beijing

• Beijing Jishuitan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Ting Li

Conditions Swelling/ Edema; Ankle fracture; Edema; Postoperative rehabilitation; horse chestnut seed extract; venostan; enhanced recovery after surgery