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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01518205
Eligibility Criteria:
Inclusion Criteria:
* Diabetic patients
* Ischemic diabetic ulcers (class I, II and III Texas Wound Classification System);
* documented peripheral vasculopathy with at least a previous event of failed revascularization (no ulcer healing).
Exclusion Criteria:
* Patient refusal to participate
* BMI \> 35 kg/m2
* Ischemic diabetic ulcers class III Texas Wound Classification System
* Patients presenting a bleeding diathesis, malignant tumor, heart failure not allowing extracorporeal technique.
* Haemodialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01518205
Study Brief:
Protocol Section:
NCT01518205