The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Venostasin (horse chestnut seed extract tablets)
  Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days
• Другое standard treatment
  standard treatment

Первичные конечные точки

• Change in ankle circumference at 6 days postoperatively compared to baseline [Срок оценки: from enrollment to the 6th day postoperation]

Вторичные конечные точки (7)

• Change in ankle circumference at 14 days postoperatively compared to baseline [Срок оценки: from enrollment to the 14th day postoperation]
• Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline [Срок оценки: from enrollment to the 14th day postoperation]
• Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively [Срок оценки: from enrollment to the 14th day postoperation]
• EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively [Срок оценки: from enrollment to the 14th day postoperation]
• Ankle range of motion at 6 and 14 days postoperatively [Срок оценки: from enrollment to the 14th day postoperation]
• Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively [Срок оценки: from enrollment to the 14th day postoperation]
• Rate of surgical complications [Срок оценки: from enrollment to 30 days after discontinuation of medication]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Jishuitan Hospital — Пекин

Идентификаторы

NCT: NCT06872034 · K2025-003-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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