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

July 14, 2025 updated by: LiTing, Beijing Jishuitan Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in ankle circumference at 6 days postoperatively compared to baseline
Time Frame: from enrollment to the 6th day postoperation
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in ankle circumference at 14 days postoperatively compared to baseline
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to the 14th day postoperation
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
Time Frame: from enrollment to 30 days after discontinuation of medication
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Jishuitan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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