Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg

Completed · Not applicable

Conditions studied: Diabetes, Healthy

In brief

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.

Key facts

Study ID

NCT01804478

Run by

University of California, San Diego

People needed

20

Starts

2005-05-01

Expected to finish

2013-02-01

Last updated by the study team

2013-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• As long as there is no exclusion criteria

You may not qualify if…

• History of lower extremity vascular diseases such as atherosclerosis, intermittent claudication, acute or chronic deep venous thrombosis, presence of ankle edema, stasis dermatitis, active lower extremity ulcers or wounds, diabetic foot ulcers, diabetic neuropathy, history of lower extremity surgery.
• Pregnant women.
• Patients with abnormally large or misshapen legs.
• Patients with existing ulcers.
• Patients with poor underlying health.
• Patients with allergies to the study materials.
• Patients who recently developed deep venous thrombosis (6 months)
• Patients with congenital A/V malformations.
• Patients with paraplegia.

Where it is running

• University of California San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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