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

Beijing Jishuitan Hospital

Status

Enrolling

Conditions

Swelling/ Edema

Treatments

Drug: Venostasin (horse chestnut seed extract tablets)

Other: standard treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06872034

K2025-003-00

Details and patient eligibility

About

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.

Enrollment

290 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.