Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06872034

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

Led by Beijing Jishuitan Hospital · Updated on 2025-07-16

290

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Diagnosed with ankle fracture confirmed by imaging with AO classification: AO-43, AO-44-F3, or AO-44
  • Scheduled to undergo open reduction and internal fixation surgery
  • Voluntary signing of informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Contraindications to surgery
  • Severe combined injuries or soft tissue infections
  • Severe multiple trauma with Injury Severity Score (ISS) greater than 16
  • Concurrent fractures of spine, pelvis, or lower limbs (ipsilateral or contralateral)
  • Pathological fractures
  • Peripheral vascular disease or deep vein thrombosis (DVT)
  • Severe impairment of heart, lung, liver, or kidney function or abnormal coagulation
  • Unable to walk independently before injury
  • Pre-existing lower limb edema before injury (e.g., due to liver cirrhosis, kidney disease)
  • Mental disorders or hyperalgesia
  • Allergy to any component of the investigational drug
  • Any contraindications limiting clinical evaluation and treatment
  • Deemed unsuitable for inclusion by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Beijing Jishuitan Hospital

Beijing, China, 100035

Actively Recruiting

Loading map...

Research Team

T

Ting Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here