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:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT04883892
Eligibility Criteria:
Inclusion Criteria:
1. Patients with degenerative ankle cartilage disease;
2. Unilateral involvement on the ankle;
3. Signs and symptoms of degenerative pathology of the ankle cartilage;
4. Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
5. No clinically significant electrocardiographic changes (recently performed ECG).
6. Ability and consent of patients to actively participate in clinical follow-up;
Exclusion Criteria:
1. Patients unable to give consent;
2. Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
3. Patients who have undergone ankle surgery in the preceding 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncompensated diabetes;
9\. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04883892
Study Brief:
Protocol Section:
NCT04883892