A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) During Vascular Occlusion

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01484730
First received: November 29, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Researcher at Beckman Laser Institute have developed many non-invasive imaging modalities for evaluation of skin blood flow. In this study the researcher can use Multi-Spectral Imaging and Laser Speckle Imaging device during Vascular Occlusion on the skin.

The purpose of this research is to evaluate and validate the performance of non-invasive imaging modalities for assessment of skin. A pressure cuff occlusion will be used to stimulate blood flow dynamics that these instruments are designed to sense.


Condition Intervention
Abnormal Vascular Flow
Device: Multi-Spectral & Laser Speckle Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) During Vascular Occlusion

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The MI/LSI devices can determine changes in skin tissue and skin blood flow during skin occlusion


Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Multi-Spectral & Laser Speckle Imaging
Multi-Spectral & Laser Speckle Imaging
Device: Multi-Spectral & Laser Speckle Imaging
Changes in skin tissue and blood flow.
Other Name: Multi-Spectral & Laser Speckle Imaging

Detailed Description:

The primary reason for including pressure cuff occlusion in this protocol is to test the performance of MI technologies in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • Male and female adult 18 years and older

Exclusion Criteria:

  • Younger than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484730

Locations
United States, California
Beckman Laser Institute, UCI
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Anthony Durkin, PhD Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01484730     History of Changes
Other Study ID Numbers: NIH/LAMMP33029
Study First Received: November 29, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014