Status:
UNKNOWN
The Mount Sinai Diabetic Foot Ulcer Prospective Trial
Lead Sponsor:
Windsor Ting
Conditions:
Diabetes
Diabetic Foot Ulcer
Eligibility:
All Genders
30-64 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken car...
Detailed Description
This will be a single center, patient-blinded, randomized controlled trial. In the event that a patient does not meet inclusion criteria after signing the consent for and undergoing venogram/IVUS (scr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03404895
Start Date
April 13 2018
End Date
December 1 2024
Last Update
November 18 2023
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029