Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT06137820
Eligibility Criteria:
Inclusion Criteria:
1. Signing the Patient Information Sheet and Informed Consent Form
2. Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
3. Men or women aged ≥20 and ≤80 years
4. Patients who mark the pain 4 cm on a VAS
5. Patients who are willing or able to follow doctor's instructions
6. Patients not participating in other clinical trials within 30 days before the screening
7. Patients who have received sufficient explanation for this clinical trial and agreed to participate
Exclusion Criteria:
1. Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
2. Ankle surgery in the previous six months
3. Topical NSAIDs application during the treatment period
4. BMI \> 32
5. Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
6. Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
7. Patients with major infections in the observation period
8. Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
9. Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range)
10. Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
11. Patients who received systemic steroid treatment within 1 month prior to their first visit
12. Diabetic foot
13. Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT06137820
Study Brief:
Protocol Section:
NCT06137820