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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT06353568
Eligibility Criteria:
Inclusion Criteria:
* Individuals diagnosed with type 2 Diabetes Mellitus (according to American Diabetes Association 2021 criteria),
* both sexes,
* between 18 and 75 years,
* Individuals classified, according to the International Working Group on the Diabetic Foot (IWGDF- 2019) scale, as moderate to high risk for developing diabetic foot,
Exclusion Criteria:
* Pregnant women
* Individuals diagnosed with type 1 diabetics,
* Individuals with neuropathy secondary to uncontrolled conditions (hypothyroidism, vitamin B12 deficiency, alcoholism),
* Individuals diagnosed with active infectious condition at the time of inclusion,
* Individuals diagnosed with active ulcer or infectious skin lesion on the legs/feet,
* Individuals with historic of osteomyelitis,
* Individuals with Parkinson's disease,
* Individuals with contracture condition,
* Individuals with severe lower limb ischemia (Fontaine III and IV - Rutherford 4 to 6),
* Individuals with a suspicious skin lesion for neoplasms or cutaneous dysplasias on the legs/feet
* Individuals diagnosed with oncologic disease or undergoing treatment within the last 3 (three) months,
* Individuals presenting unstable angina, recent acute myocardial infarction, history of severe arrhythmia within the last six months,
* Individuals diagnosed with decompensated Chronic Obstructive Pulmonary Disease (COPD),
* Inability to understand the ICF,
* Inability to attend appointments regularly.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06353568
Study Brief:
Protocol Section:
NCT06353568