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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT03239457
Eligibility Criteria:
Inclusion Criteria:
Diagnosis of diabetic foot ulcer,University of Texas Wound Classification AI-AII and CI-CII with or without ischemia at least of 4 weeks of evolution Ulcers with an area between ≥ 2 cm2 or greater (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue) Patients with age than 22 years. Voluntariness of the patient by signing up the informed consent, and written form signed the date prior to study.
Exclusion Criteria:
Hemoglobin ≤100 g/L. Patients with a significant acute cardiovascular event (Major Acute Cardiovascular Event) within 3 months prior such as acute myocardial infarction, severe angina pectoris, acute stroke or transient ischemic attack, and/or thrombo-embolism event.
Patients with chronic uncompensated diseases: diabetic coma, or renal failure (creatinine 200 mmol/L and oligoanuria).
Antecedents or suspicion of malignant diseases (general physical examination, rectal tact, examination of breast, abdominal ultrasound, thorax radiography and blood hemochemistry).
Psychiatric diseases that compromise the treatment or the evaluations Infection Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03239457
Study Brief:
Protocol Section:
NCT03239457