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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT06680856
Eligibility Criteria:
Inclusion Criteria:
1. Males and females
2. Between the ages of 40 and 90 years
3. Diagnosis of diabetes: random glycaemia \>126 mg in more sample or second hour oral Glucose Tolerance Test glycaemia \>200 mg or glycosylated hemoglobin \>6.5 mmol/L
4. The cross-sectional area of the index ulcer will be between 25 and 2000 mm2
5. Injury-trophic level Grade I, II, Level A and B (according to Texas classification)
6. Ankle Brachial Index \>0.5
7. The patient's willingness to cooperate with the physician in follow-up
8. No previous treatment with platelet derivatives
9. Negative serum pregnancy test within 7 days prior to commencement the treatment in premenopausal women.
10. Fertile women must use an effective method of contraception during the treatment and for at least 6 months after completion of treatment as directed by their physician.
11. Signature of the informed consent form
Exclusion Criteria:
1. Have End-Stage Renal Disease (ESRD-stage 5 of kidney disease), or severe heart failure which may require organ transplantation
2. Are breast-feeding.
3. Have a previous or current history of malignant neoplastic disease within the past 5 years
4. Have neuropsychiatric diseases that may interfere with the patient's ability to collaborate in the study.
5. They have any condition that, in the doctor's judgment, could endanger them.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT06680856
Study Brief:
Protocol Section:
NCT06680856