Abnormal Vascular FlowNCT01484730
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
An observational study of Abnormal Vascular Flow, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormal Vascular Flow
- What is being tested?
- Multi-Spectral and Laser Speckle Imaging
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from University of California Irvine, student and staff member.
Who may be able to join
- Male and female adult 18 years and older
Who cannot join
- Younger than 18 years of age
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
Anthony Durkin, PhD, 949-824-3284, adurkin@hs.uci.edu
Kristen Kelly, MD
About this study
Official title: A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) and Multiphoton Microscopy (MPM) During Vascular Occlusion
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.
Read the detailed description
The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).
- Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
- Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.
- Conditions
- Abnormal Vascular Flow
- Being tested
- Multi-Spectral and Laser Speckle Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Spectral and Laser Speckle ImagingDevice
Changes in skin tissue and blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Vascular Occlusion | Multi-Spectral and Laser Speckle Imaging Receives: Device: Multi-Spectral and Laser Speckle Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Vascular FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Anthony Joseph Durkin, University of California, Irvine
- Investigators
- Anthony Durkin, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484730
- Sponsor's protocol ID
- 20118370
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2011
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) and Multiphoton Microscopy (MPM) During Vascular Occlusion
- ClinicalTrials.gov ID
- NCT01484730
- Acronym / sponsor ID
- 20118370
- Conditions
- Abnormal Vascular Flow
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Nov 2011
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).
- Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
- Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular Occlusion | – | Device: Multi-Spectral and Laser Speckle ImagingMulti-Spectral and Laser Speckle Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from University of California Irvine, student and staff member.
Key inclusion criteria (1 listed)
- Male and female adult 18 years and older
Key exclusion criteria (2 listed)
- Younger than 18 years of age
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Spectral and Laser Speckle ImagingChanges in skin tissue and blood flow. | Device | Vascular Occlusion |
Primary outcome
Skin blood flow
Time frame: 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Durkin, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Vascular Flow, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordon Kennedy, PhD (949-824-4713, gordon.kennedy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin blood flow (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.