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NCT01804478 · ClinicalTrials.gov registry record · NA
Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg
A NA study of Healthy and Diabetes, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01804478 is a NA study of Healthy and Diabetes that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01804478, a NA study of Healthy and Diabetes, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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.
Interventions
- BEHAVIORAL Mild pneumatic compression
Study Locations (1)
California
- University of California San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-05 |
| Est. Completion | 2013-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01804478
The ClinicalTrials.gov registry entry for NCT01804478 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Mild pneumatic compression is the first listed.
NCT01804478 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01804478 about?
NCT01804478 is a clinical study titled "Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg". 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 i...
What is the current status of trial NCT01804478?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2005-05. Estimated completion is 2013-02.
What conditions does trial NCT01804478 study?
This clinical trial studies the following conditions: Healthy, Diabetes.
What interventions are being tested in trial NCT01804478?
The interventions under investigation include: Mild pneumatic compression (BEHAVIORAL).
Who is sponsoring clinical trial NCT01804478?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01804478 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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