Clinical trial NCT06872034: The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Swelling/ Edema
Keywords: Ankle fracture
Edema
Postoperative rehabilitation
horse chestnut seed extract
venostan
enhanced recovery after surgery
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in ankle circumference at 6 days postoperatively compared to baseline
timeFrame: from enrollment to the 6th day postoperation
Secondary outcomes:
measure: Change in ankle circumference at 14 days postoperatively compared to baseline
timeFrame: from enrollment to the 14th day postoperation
measure: Percentage change in ankle circumference at 6 and 14 days postoperatively compared to baseline
timeFrame: from enrollment to the 14th day postoperation
measure: Change in Visual Analog Scale (VAS) pain score at 6 and 14 days postoperatively
timeFrame: from enrollment to the 14th day postoperation
measure: Olerud-Molander Ankle Score (OMAS) at 6 and 14 days postoperatively
timeFrame: from enrollment to the 14th day postoperation
measure: EuroQol-5 dimension (EQ-5D) score at 6 and 14 days postoperatively
timeFrame: from enrollment to the 14th day postoperation
measure: Ankle range of motion at 6 and 14 days postoperatively
timeFrame: from enrollment to the 14th day postoperation
measure: Incidence of deep vein thrombosis (DVT) in the lower limbs within 14 days postoperatively
timeFrame: from enrollment to the 14th day postoperation
measure: Rate of surgical complications
timeFrame: from enrollment to 30 days after discontinuation of medication
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
Study officials:
References: