Ankle sprain
Conditions
Interventions
Trial group:Local administration of exosomes derived from human umbilical cord mesenchymal stem cells
Placebo group :Local administration of normal saline
Sponsors
The Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 60 years (inclusive), regardless of gender; 2. No significant abnormalities detected on X-ray or CT imaging, with MRI diagnosis confirming bone contusion with bone marrow edema or soft tissue injury around the ankle joint; 3. Presence of clinical signs such as swelling and tenderness around the ankle joint, with pain on inversion; 4. Grade II ankle ligament injury resulting from blunt trauma (e.g., twisting, falling, or direct impact), causing pain or tenderness in adult patients, with the injury occurring within the past year; 5. Patients meeting the indications for local injection therapy for ankle edema in the lower extremity; 6. The participant and/or their legal guardian is willing and able to provide informed consent, demonstrates good compliance, and is willing and able to follow medical advice and complete required follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with ankle swelling during the recovery phase clearly attributed to non-traumatic causes, such as acute heart failure, nephrotic syndrome, deep vein thrombosis, or other systemic conditions leading to lower extremity edema; 2. Patients who participated in another clinical trial within 3 months prior to the start of this study or are currently using medications that may interfere with the investigational treatment; 3. Patients with open ankle injuries, or those with concomitant contusions or fractures at other sites, or additional soft tissue injuries in other parts of the lower extremity; 4. Patients with definite ankle instability, ankle deformity, or malalignment; 5. Patients with coexisting joint disorders such as gouty arthritis, rheumatoid arthritis, or osteoarthritis; 6. Patients unable to tolerate the treatment due to comorbidities such as acute or chronic infectious diseases, connective tissue diseases, malignancies, or ischemic/hypoxic conditions; 7. Patients with poor compliance, unwilling or unable to adhere to post-treatment protocols and/or rehabilitation instructions; or those who are mentally incapable of understanding or fulfilling the requirements of study participation; 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage decrease in edema degree;Functional Ankle and Ankle Module;American Orthopaedic Foot & Ankle Society Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (including vital signs, laboratory tests, complications, other adverse events, and concomitant medications at 1 week, 1 month, 3 months, and 6 months post-treatment); | — |
Countries
China
Contacts
Public ContactGuo Quanyi
The Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed