Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Beijing Jishuitan Hospital
Beijing, China, 100035
Actively Recruiting
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
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