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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03404895
Eligibility Criteria:
Inclusion Criteria:
* Presence of diabetic foot ulcer within the foot (located distal to the ankle and proximal to base of toes)
* Lower extremity edema
* MRA or CTA showing stenosis of iliac vein or indirect findings that suggest presence of iliac vein stenosis (distal venous dilation and presence of collateral veins)
* At least one palpable pedal pulse or ABI\>0.9 IVUS confirmation of iliac vein stenosis
Exclusion Criteria:
* Previous vein stent implantation involving study leg or inferior vena cava
* Previous bypass surgery or endovascular intervention involving study leg
* Known metal allergy
* Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
* Acute deep venous thrombosis involving either leg
* Known history of chronic occlusion of any vein in the study leg
* Venous compression caused by tumor encasement
* Venous outflow obstruction caused by tumor thrombus
* Elevated baseline blood creatinine (\>1.5)
* Pregnancy
* Life expectancy \<12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
64 Years
Study:
NCT03404895
Study Brief:
Protocol Section:
NCT03404895