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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT05757258
Eligibility Criteria:
Inclusion Criteria:
* age of at least 18 years
* diagnosis of T2DM present for a least one year
* Ankle/Brachial Index (ABI) of less than 0.80
* lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
* category 4 or 5 of PAD in accordance with the Rutherford classification
* presence of CLTI requiring endovascular treatment
Exclusion Criteria:
* pregnancy
* acute infections at present or in the previous month
* diabetic foot ulcers with sign of infection or osteomyelitis
* previous lower-limb endovascular or surgical revascularization within the past 3 months
* diabetic peripheral neuropathy
* liver disease with a functional status B or C in accord to Child-Pugh classification
* congenital or acquired thrombophilia
* active autoimmune disease
* active cancer
* organ transplantation
* life expectancy \< 12 months
* contraindication to antiplatelet therapy
* contraindication to endovascular revascularization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05757258
Study Brief:
Protocol Section:
NCT05757258