The Mount Sinai Diabetic Foot Ulcer Prospective Trial

ID#: NCT03404895

Age: 30 - 64 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 13, 2018

End Date: February 01, 2019

Contact Information:
Sarah Mccracken
(212) 241-8708
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 care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.

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