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NCT00969722
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.
NCT01804478
SPECIFIC AIMS The limbs of diabetic patients are associated with decreases in capillary density, arterial inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing and viability of tissue, especially in patients with peripheral vascular disease and diabetes. The investigators hypothesize that mild external compression can restore the decreases in skin and muscle blood flow and that there would be greater increases in microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow will be measured using Photoplethysmography (PPG) before, during, and after external compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS). The specific aims are: * To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF) microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes. * To measure muscle oxygenation changes in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes. * To optimize pressures of Continuous Compression to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes. * To optimize compression pressures, duration, and frequency of Intermittent Pneumatic Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes. * To measure microcirculatory response to compression in patients with diabetes * Continue to validate of photoplethysmography as a tool for measuring microcirculation.