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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venostan (horse chestnut seed extract tablets) | Experimental |
| |
| control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venostasin (horse chestnut seed extract tablets) | Drug | Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from enrollment to the 6th day postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from enrollment to the 14th day postoperation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Li | Contact | 86-010-58517207 | liting2000@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Recruiting | Beijing | 100035 | China |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C039661 | venostasin |
| C517354 | horse chestnut seed |
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| standard treatment | Other | standard treatment |
|
| 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) | from enrollment to the 14th day postoperation |
| 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 | from enrollment to the 14th day postoperation |
| 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 | from enrollment to the 14th day postoperation |
| Ankle range of motion at 6 and 14 days postoperatively | Defined as the ankle range of motion assessed by the investigator through physical examination on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) | from enrollment to the 14th day postoperation |
| Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively | Defined as the incidence of deep vein thrombosis (DVT) detected by lower limb vascular ultrasound within 14 days postoperatively | from enrollment to the 14th day postoperation |
| Rate of surgical complications | Defined as complications related to the fracture surgery, with the severity of complications assessed by the investigator using the Clavien-Dindo classification of surgical complications | from enrollment to 30 days after discontinuation of medication |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |