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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT02554851
Eligibility Criteria:
Inclusion Criteria:
1. DM type 1 or 2 diagnosis
2. DFU persisting for a minimum of 4 weeks If the participant have more than one DFU, then it will be treated the one with the largest extension and that follows the inclusion and exclusion criteria.
3. DFU 's rating according to the PEDIS system:Perfusion: grades 1 or 2; Extension: Area ≥ 2 cm2; Depth: grades 2 or 3; Infection: grades 1 or 2; Sensitivity: grade 2
If the consented participant is classified as having infection grade 3 without the presence of osteomyelitis, it will be possible to treat it with antibiotics empirically. However, randomization will be made only after this treatment and only if the infection has regressed to grade 1 or 2;
Exclusion Criteria:
1. Age less than 18 years;
2. Pregnancy or breastfeeding (women in childbearing age will need to use a contraception method);
3. Evidence of bone involvement : direct visualization of bone structures; positive survey (probe to bone) ; image investigation (simple x-ray or MRI);
4. Urgent or imminent need of amputation;
5. Eminent indication for revascularization;
6. Glycated hemoglobin (HbA1c) counted greater than 11 %
7. Use of drugs that can affect or contribute to the healing of ulcers as corticosteroids; immunosuppressive; chemotherapy; other growth factors;
8. Clinical signs of malnutrition or serum albumin \<30 g / L;
9. Angina pectoris classified as 3 or 4 (according to the Canadian Cardiovascular Society Angina Classification);
10. Congestive heart failure class IV (according to the New York Heart Association);
11. Severe hepatic impairment, defined as ALT and / or AST greater than 5 (five) times the normal maximum reference value;
12. Acute renal failure, defined as serum creatinine levels equal or higher than 1.5 times the baseline value in the last 7 days (according to KDIGO and RIFLE classification);
13. End-stage renal disease (creatinine clearance equal or lower than 30 ml / min or on dialysis);
14. History or suspected neoplasia (according to previous laboratory tests, imaging or biopsy);
15. Psychiatric disorders that may alter the participants evaluation, or prevent proper consent and / or cognitive aspects that demonstrate the possibility of noncompliance with treatment or the adoption of aseptic criteria;
16. Occurrence of the following events 30 days prior to inclusion in the protocol: participation in other clinical studies; hypoglycemic coma (blood glucose less than or equal to 30 mg / dL with loss of consciousness or need for help); diabetic ketoacidosis or hyperosmolar state within 30 days prior to inclusion;
17. Occurrence of the following events 60 days prior to inclusion in the protocol: hospitalization for acute coronary syndrome, percutaneous intervention (eg cardiac, cerebrovascular, aortic) or greater cardiac surgery; myocardial infarction; cerebrovascular accident; cardiac arrest; sustained ventricular tachycardia; acute coronary syndrome, in investigator opinion; uncontrolled severe hypertension, defined as systolic blood pressure equal or higher than 180 mmHg and / or diastolic blood pressure equal or higher than 110 mmHg;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02554851
Study Brief:
Protocol Section:
NCT02554851