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

N/ARecruitingNCT06872034

Beijing Jishuitan Hospital290 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

290

Conditions

Swelling/ Edema

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: from enrollment to the 6th day postoperation

Secondary Outcomes

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)