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.
≥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.
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;
Parallel
Venostasin (horse chestnut seed extract tablets)
DrugVenostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days
standard treatment
Other interventionstandard treatment
Change in ankle circumference at 6 days postoperatively compared to baseline
Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 6 (after 5 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Change in ankle circumference at 14 days postoperatively compared to baseline
Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 14 (after 13 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline
Defined as the percentage change in ankle circumference measured using the figure-of-eight method on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)
Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively
Defined as the change in the patient-reported Visual Analog Scale (VAS) pain score on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the score on postoperative day 2，VAS range from 0 to 10, and higher scores mean a worse outcome
EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively
Defined as the EuroQol-5 dimension (EQ-5D) quality of life score reported by the patient on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively), EQ-5D consists of 5 dimension, and every dimension consists of 5 level, the higher lever means a worse outcome
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