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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT03250533
Eligibility Criteria:
Inclusion Criteria:
* Age range from 30 to 65 years;
* Diabetic patients with neuropathic, ischemic or neuroischemic ulcers in the legs and / or feet;
* With a duration of 4 weeks or more;
* Being grade I and / or II lesions by the Meggitt-Wagner classification;
* Have a good degree of cognition evaluated by the Mini-Mental State Examination - MEEM (Brucki et al., 2003);
* Be under medical supervision and perform regular dressings and debridements of the wound.
Exclusion Criteria:
* Those presenting with an associated disease, such as renal, neurological, immunological, hematological or hepatic disease, which may interfere with evaluation and / or therapeutic procedures, and which are not related to diabetes;
* Malignancies (carcinomas);
* Use of medications that alter the healing process (corticosteroids, immunosuppressants, among others);
* Clinical signs of infection (sepsis), acute cellulitis, osteomyelitis or gangrene;
* Those who do not agree to sign the Free and Informed Consent Form;
* And who do not meet the inclusion criteria described.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT03250533
Study Brief:
Protocol Section:
NCT03250533