The Mount Sinai Diabetic Foot Ulcer Prospective Trial

Launched by WINDSOR TING · Jan 12, 2018

Keywords

ClinConnect Summary

The Mount Sinai Diabetic Foot Ulcer Prospective Trial is studying whether placing stents in a blocked vein in the leg can help heal diabetic foot ulcers, which are sores that often occur in people with diabetes. These ulcers can be slow to heal and may lead to serious complications, including infections and amputations. The researchers are looking at patients who have both foot ulcers and swelling in their legs caused by a blockage in a major vein called the iliac vein. They believe that treating this blockage with stents may improve blood flow and help the ulcers heal better.

To participate in the trial, patients need to have a diabetic foot ulcer located on their foot, swelling in the legs, and evidence of a blockage in the iliac vein. Participants will be randomly assigned to either receive a stent or not, but everyone in the study will receive the standard care for diabetic foot ulcers, which may include wound care, antibiotics, and pressure relief. This study is important because it could lead to a new treatment option for patients struggling with diabetic foot ulcers, improving their chances of healing and reducing serious complications.

Gender

ALL

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