CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Mild pneumatic compressionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01804478
NCT01804478N/ACompleted

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

University of California, San Diego·interventional·Posted Mar 5, 2013·Updated Mar 5, 2013

In Brief

A clinical study evaluating Mild pneumatic compression for Diabetes and Healthy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Healthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2013
Enrollment StartMay 1, 2005
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 13.3 years ago

Interventions

Mild pneumatic compressionbehavioral