MACROVASCULAR AND MICROVASCULAR PERFUSION ASSESSMENT OF ISCHEMIC DIABETIC ULCERS USING MRI

Investigator: Dipan Shah, MD

Study Coordinator: Bevin Lopez

Status: Enrolling

ClinicalTrials.gov Number: NCT00000000

Phone: 713.441.6537

IRB Number: Pro00009510

Description

The American Diabetes Association estimates that 25.8 million individuals or 8.3% of the United States population have diabetes mellitus (DM). Individuals with diabetes have an increased risk for cardiovascular disease (CVD) and CVD events account for over 60% of all deaths in diabetics. Approximately 25% of diabetics will develop a lower extremity or foot ulcer during their lifetime. Amputation is one of the most feared complications in patients with diabetes which it typically preceded by a non-healing ulcer. Some patients with diabetes also present with peripheral arterial disease (PAD) which is a malignant form of atherosclerosis that results in plaque build-up in the arteries of the legs. Diabetics with PAD have worse ulcer healing rates compared with patients without PAD. Clinically, we do not understand why ulcers do not heal in some patients. We propose to study the relationship between ulcer healing and blood flow (perfusion) in the leg arteries and blood flow in the leg muscle using magnetic resonance imaging (MRI). MRI uses radio waves produced by a large magnet and the body’s response to the radio waves to create pictures of the inside of the body. Arterial and leg muscle perfusion will be measured from the MRI images. The proposed imaging assessment could help in the clinical management of patients with non-healing diabetic ulcers.
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