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

NCT06872034 | Recruiting

• 1 other identifier: K2025-003-00
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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

Swelling/ Edema

Keywords

Ankle fracture; Edema; Postoperative rehabilitation; horse chestnut seed extract; venostan; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• 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)

  from enrollment to the 6th day postoperation

Secondary Outcomes (7)

• Change in ankle circumference at 14 days postoperatively compared to baseline

  from enrollment to the 14th day postoperation

• Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline

  from enrollment to the 14th day postoperation

• Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively

  from enrollment to the 14th day postoperation

• EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively

  from enrollment to the 14th day postoperation

• Ankle range of motion at 6 and 14 days postoperatively

  from enrollment to the 14th day postoperation

Study Arms (2)

Venostan (horse chestnut seed extract tablets)

EXPERIMENTAL

Drug: Venostasin (horse chestnut seed extract tablets); Other: standard treatment

control

OTHER

Other: standard treatment

Interventions

Venostasin (horse chestnut seed extract tablets) DRUG

Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days

Venostan (horse chestnut seed extract tablets)

standard treatment OTHER

standard treatment

Venostan (horse chestnut seed extract tablets); control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, 100035, China

RECRUITING

MeSH Terms

Conditions

Edema; Ankle Fractures

Interventions

venostasin; horse chestnut seed

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Central Study Contacts

Ting Li

CONTACT

86-010-58517207; liting2000@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 12, 2025
• Study Start: April 16, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)