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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT03935659
Eligibility Criteria:
Inclusion Criteria: One or more of the following
* Body Mass Index \>30 kg/m2
* Critical limb ischemia defined by Ankle Brachial Index\<0.35, rest pain, tissue loss and/or non-healing ulcers
* Procedure time \>240 min
* End Stage Renal Disease on dialysis
* Glycated hemoglobin ≥ 8.5%
* Transfusion ≥ 3 units packed Red Blood Cells
* Previous femoral artery cut-down
Exclusion Criteria:Any of the following
* Preexisting groin infection
* Complete vacuum seal cannot be achieved with negative pressure device
* Allergy to Adhesive Material
* Groin Surgery within last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03935659
Study Brief:
Protocol Section:
NCT03935659