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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT05243368
Eligibility Criteria:
Inclusion Criteria:
* Signature of the informed consent
* Age between 50 and 80 years
* Diagnosis of Diabetes Mellitus for more than 1 year
* Documented diagnosis of peripheral artery disease
* HbA1c \< 9%
* Category 5 in the Rutherford-Becker classification
Exclusion Criteria:
* Poor cognitive function, dementia or psychiatric conditions
* Osteomyelitis, gangrene, malignancy or immunocompromised disease
* Thromboangiitis obliterans or Buerger's disease
* Clinical evidence of invasive infection in the target limb requiring IV antibiotherapy
* Presence of neuropathic ulcers only
* Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT05243368
Study Brief:
Protocol Section:
NCT05243368