The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venostasin (horse chestnut seed extract tablets), standard treatment.
- Who it may be relevant to
- Registry conditions: Swelling/ Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Venostasin (horse chestnut seed extract tablets)
Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days - Other standard treatment
standard treatment
Primary outcome measures
- Change in ankle circumference at 6 days postoperatively compared to baseline [Time frame: from enrollment to the 6th day postoperation]
Secondary outcome measures (7)
- Change in ankle circumference at 14 days postoperatively compared to baseline [Time frame: from enrollment to the 14th day postoperation]
- Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline [Time frame: from enrollment to the 14th day postoperation]
- Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively [Time frame: from enrollment to the 14th day postoperation]
- EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively [Time frame: from enrollment to the 14th day postoperation]
- Ankle range of motion at 6 and 14 days postoperatively [Time frame: from enrollment to the 14th day postoperation]
- Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively [Time frame: from enrollment to the 14th day postoperation]
- Rate of surgical complications [Time frame: from enrollment to 30 days after discontinuation of medication]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Jishuitan Hospital — Beijing
Identifiers
NCT: NCT06872034 · K2025-003-00