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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT01522495
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years or older.
* Subject has PVD demonstrated by angiogram.
* Subject is undergoing the first amputation/debridement after vascular intervention, if intervention is/was warranted.
* Subject has had a vascular consult and/or intervention.
* Subject must sign an IRB approved informed consent.
* Subject is willing and able to complete required follow up.
Exclusion Criteria:
* Subject has no evidence of PVD
* Subject's wound presents with a malignancy in the wound bed.
* Subject has liver disease (Previously diagnosed with liver disease or elevated AST, ALT, Alk Phos, or Bilirubin labs within 30 days of procedure).
* Subject has a disorder or situation that the investigator believes will interfere with study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01522495
Study Brief:
Protocol Section:
NCT01522495