A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion

NCT01484730 | Recruiting

• 1 other identifier: 20118370
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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 dynamic that these instruments are designed to sense. The researcher currently plan to assess only basic feasibility of the imaging instruments.

Conditions

Abnormal Vascular Flow

Outcome Measures

Primary Outcomes (1)

• Skin blood flow

  The key factor of interest is measuring the changes in the fluorescence signal of the epidermal cells during the arm occlusion, which will provide information about changes in cellular metabolism during cellular oxygen deprivation. Time series of optical sections (two-dimensional x-y images parallel to the skin surface of about 250x250 µm2) at the same depth will be obtained before, during and after the arm occlusion. The images will be based on two-photon excitation of endogenous fluorophores (NADH). To quantify the fluorescence signal, which will provide information about changes of cellular metabolism, we will use the integrated brightness of each image (same rectangular area for all images) as a measure of the signal. The integrated brightness is defined as the sum of pixels weighted over the brightness values (or gray values) of the pixel. A statistical plan is not appropriate at this stage of the pilot study.

  4 weeks

Study Arms (1)

Vascular Occlusion

Multi-Spectral and Laser Speckle Imaging

Device: Multi-Spectral and Laser Speckle Imaging

Interventions

Multi-Spectral and Laser Speckle Imaging DEVICE

Changes in skin tissue and blood flow.

Vascular Occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from University of California Irvine, student and staff member.

You may qualify if:

• Male and female adult 18 years and older

You may not qualify if:

• Younger than 18 years of age
• Pregnant women

Sponsors & Collaborators

• University of California, Irvine: lead
• United States Department of Defense: collaborator

Study Sites (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

RECRUITING

MeSH Terms

Interventions

Laser Speckle Contrast Imaging

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Anthony Durkin, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon Kennedy, PhD

CONTACT

949-824-4713; gordon.kennedy@uci.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher, BME & Surgery, Director, Laboratory for Functional Imaging Lab

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)