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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT05999656
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18-80 years;
2. Meet the diagnostic criteria of diabetic foot by International Clinical Guidelines for Diabetic Foot;
3. Ulcer course ≥8 weeks, Wagner grade ≥2;
4. There was no healing trend (no reduction in wound size and no obvious new granulation tissue) after 4 weeks or above treatment. Or the ulcer was further aggravated (by Wagner's grade assessment) in the course of standardized treatment;
5. Fasting blood glucose ≤9mmol/L, 2h postprandial blood glucose ≤13mmol/L;
6. Signing informed consent.
Exclusion Criteria:
1. Patients with a history of ketoacidosis and hyperosmosis within 6 months;
2. Patients with viral infection (treponema pallidum, active hepatitis, HIV, Epstein-Barr virus, etc.)
3. Patients with malignant disease or cured of basal cell carcinoma within the past 5 years;
4. Creatinine clearance \< 45ml/min;
5. Patients with severe heart failure (NYHA III-IV);
6. Patients with a history of myocardial infarction or cerebral infarction in the last 3 months;
7. Patients who have received cell or growth factor therapy in the past year;
8. Patients during pregnancy or lactation;
9. Patients with abnormal thyroid dysfunction history or abnormal control through drug treatment;
10. Patients with severe hepatic failure (ALT, AST: above 3 times the upper limit of normal);
11. Lower extremity arterial with large artery occlusion by ultrasound image;
12. Patients with a history of severe coagulation disorder or hemorrhagic disease;
13. Patients with sequelae of cerebral infarction or other reasons that cannot extend their lower limbs flat;
14. Patients with psychological or mental disorders who cannot cooperate with treatment;
15. Participate in other clinical research within the past three months;
16. Patients are unable to complete the study or comply with the requirements of the study by investigator's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05999656
Study Brief:
Protocol Section:
NCT05999656