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NCT Number: NCT06872034

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

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.

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Key information

Conditions

Swelling/ Edema Ankle Fractures Ankle Injuries Edema Fractures, Bone Leg Injuries Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Jishuitan Hospital

Beijing, 100035, China

Location status: Recruiting

Location contact

Li

CONTACT

Ting Li

CONTACT

[email protected]

010-58516688

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venostasin (horse chestnut seed extract tablets)

Drug

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

standard treatment

Other

standard treatment

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Li

CONTACT

[email protected]

86-010-58517207

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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