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

NCT01804478 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-03-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Mild pneumatic compression

Sponsors & Collaborators

Principal Investigators

  • Alan R Hargens, PhD · University of California, San Diego

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804478 on ClinicalTrials.gov