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

Launched by BEIJING JISHUITAN HOSPITAL · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Venostan, which is made from horse chestnut seed extract, to see if it can help reduce swelling after surgery for ankle fractures. The trial will include patients aged 18 and older who have been diagnosed with specific types of ankle fractures and are scheduled for surgery to fix the fracture. Participants will be randomly assigned to receive either Venostan or standard treatment after their surgery.

If you or a family member are considering participating in this trial, you will need to sign a consent form to show you understand the study. During the trial, researchers will check how the treatment affects ankle swelling, movement, and any side effects. However, certain people cannot participate, such as those who are pregnant, have severe health issues, or have specific injuries that could complicate their care. This study is important because it aims to find better ways to manage swelling and improve recovery after ankle surgery.

Gender

ALL

Eligibility criteria

• 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.