This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At least 18 years of age
✓. Normal (0.9-1.2) Ankle Brachial Index
✓Inclusion Criteria for PAD Patient Population:
✓. At least 18 years of age
✓. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by CT angiography, ultrasound, or MR imaging or an abnormal ankle-brachial index or toe-brachial index
✓. Previously diagnosed diabetes mellitus (type I or II), based on any of the following criteria: fasting plasma glucose great than 126 mg/dl on 2 separate occasions, glycated hemoglobin (HbA1c) greater than 6.5% on 2 separate occasions, fasting plasma glucose greater than 200 mg/dl 2 hours following an oral glucose tolerance test on 2 separate occasions, or fasting plasma glucose and HbA1c above normal limits on same visit.
✓. scheduled for revascularization due to obstructive blood flow in the lower extremities.
Exclusion criteria
✕. Unable to give informed consent
✕. Enrolled in another trial
✕. Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
✕. Pregnant or nursing
✕
What they're measuring
1
Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities.
Timeframe: patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.
2
Assessment of lower extremity skeletal muscle perfusion in healthy control subjects compared to patients with peripheral arterial disease and diabetes using quantitative SPECT/CT imaging.