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

The Efficacy and Safety of Venostan (Horse Chestnut Seed Extract Tablets) in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures: A Multicenter, Open-Label, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Swelling/ Edema
• Intervention / Treatment: Other: standard treatment; Drug: Venostasin (horse chestnut seed extract tablets)

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Li; Phone Number: 86-010-58517207; Email: liting2000@sina.com

Study Locations

• China
  • Beijing, China, 100035
    • Recruiting
    • Beijing Jishuitan Hospital
    • Contact: Li
    • Contact: Ting Li; Phone Number: 010-58516688; Email: jishuitan3@wjw.beijing.gov.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control	Other: standard treatment; standard treatment
Experimental: Venostan (horse chestnut seed extract tablets)	Other: standard treatment; standard treatment; Drug: Venostasin (horse chestnut seed extract tablets); Venostasin (horse chestnut seed extract tablets) ，twice daily, 400 mg per dose, for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ankle circumference at 14 days postoperatively compared to baseline	Defined as the change in ankle circumference measured using the figure-of-eight method on postoperative day 14 (after 13 days of Venostan treatment) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)	from enrollment to the 14th day postoperation
Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline	Defined as the percentage change in ankle circumference measured using the figure-of-eight method on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the ankle circumference measured on postoperative day 2 (before the first dose of Venostan)	from enrollment to the 14th day postoperation
Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively	Defined as the change in the patient-reported Visual Analog Scale (VAS) pain score on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively) compared to the score on postoperative day 2，VAS range from 0 to 10, and higher scores mean a worse outcome	from enrollment to the 14th day postoperation
EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively	Defined as the EuroQol-5 dimension (EQ-5D) quality of life score reported by the patient on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively), EQ-5D consists of 5 dimension, and every dimension consists of 5 level, the higher lever means a worse outcome	from enrollment to the 14th day postoperation
Ankle range of motion at 6 and 14 days postoperatively	Defined as the ankle range of motion assessed by the investigator through physical examination on postoperative days 6 and 14 (after 5 and 13 days of Venostan treatment, respectively)	from enrollment to the 14th day postoperation
Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively	Defined as the incidence of deep vein thrombosis (DVT) detected by lower limb vascular ultrasound within 14 days postoperatively	from enrollment to the 14th day postoperation
Rate of surgical complications	Defined as complications related to the fracture surgery, with the severity of complications assessed by the investigator using the Clavien-Dindo classification of surgical complications	from enrollment to 30 days after discontinuation of medication

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): January 12, 2026
• Study Completion (Estimated): January 12, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Edema; Ankle fracture; enhanced recovery after surgery; Postoperative rehabilitation; horse chestnut seed extract; venostan
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures; Edema
• Other Study ID Numbers: K2025-003-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No