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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02790957
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or type 2 diabetes
* Men of 18-85 years or post-menopausal women \<85 years of age
* Presence of neuroischemic or ischemic diabetic wound(s) of the leg(s) / foot(s) Texas grade 3 or 4, with or without infection.
* Ability to provide informed consent.
Exclusion Criteria:
* Sepsis
* Dialysis or severe chronic kidney disease (eGFR \<20ml/min/1.73 mq)
* Advanced liver disease (defined as cirrhosis or transaminases \>3 times ULN)
* Clinically relevant abnormalities in white blood cell counts at baseline.
* Hematologic disorders (lymphoma, myeloma, acute or chronic leukemia, chronic myeloproliferative disorders)
* Known or highly suspected solid cancer
* Women with childbearing potential
* Known hypersensitivity to Mozobil (Plerixafor or its components)
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02790957
Study Brief:
Protocol Section:
NCT02790957