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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT03171259
Eligibility Criteria:
Inclusion Criteria:
All race/ethnicity categories, English or Spanish speaking, men and women
* Age ≥18 years
* Patients presenting with Rutherford Classification 4 (ischemic rest pain), or Rutherford Classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or Rutherford Classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy.
* Diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) \<40 or a skin perfusion pressure (SPP) \<40 or angiographic evidence of significant vascular disease
Exclusion Criteria:
* No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment
* Acute limb ischemia
* Unable to provide written informed consent
* Currently a prisoner
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03171259
Study Brief:
Protocol Section:
NCT03171259