HypertensionNCT03660618
LSFG-SKIN, Laser Speckle Flowgraphy
A study testing laser speckle flowgraphy in people with Hypertension and Heart Failure, run by Randy Kardon at 1 site in United States.
Trial summary
The purpose of this project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Heart Failure, Vascular Ischemia
- What is being tested?
- laser speckle flowgraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 2 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Controls
- ●Healthy normal control subjects ages 18-90
- Cardiology Subjects
- Ages 18-90
- History of dysrhythmia, heart failure, cardiac ischemia, hypertension, peripheral vascular disease
- Dermatology Subjects
Show all 23Show fewer
- Ages 18-90
- History of inflammatory and cancerous lesions
- Endocrine Subjects
- Ages 18-90
- History of diabetes, thyroid disease
- Neurology Subjects
- Ages 18-90
- History of dementia, headaches, Parkinson's, light sensitivity, stroke, TIA, multiple sclerosis
- Psychiatry Subjects
- Ages 18-90
- History of bipolar, schizophrenia, anxiety, depression
- Surgery Subjects
- Ages 18-90
- History of skin wounds(trauma, chemotherapy, radiation), thermal burns, or plastic and reconstructive surgical procedures.
- Ophthalmology Subjects
- Ages 18-90
- History of ocular disorders caused by hypo perfusion or inflammatory disorders
Who cannot join
- Controls
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Cardiology Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
Show all 24Show fewer
- 3. Dermatology Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Endocrine Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Neurology Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Psychiatry Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Surgery Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Ophthalmology Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Department of Ophthalmology
Iowa City, Iowa, 52242
About this study
The purpose of this project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure.
Read the detailed description
Laser speckle skin blood flow (LSFG-SKIN) will be recorded in normal subjects and in patients with disorders affecting skin capillary perfusion, which may include cardiovascular disorders, dermatologic disorders, skin wounds, ocular disorders, psychiatric disorders, and neurologic disorders.
- Conditions
- Hypertension, Heart Failure, Vascular Ischemia, Burns, Chemotherapy Effect, Radiation Injuries
- Being tested
- laser speckle flowgraphy
- Keywords
- perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke
- Medical subject headings
- Hypertension, Heart Failure, Burns, Radiation Injuries, Uveitis, Scleritis, Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser speckle flowgraphyDevice
blood flow state of the skin as real time two dimensional image
| Study group | Role | What they receive |
|---|---|---|
| Clinic Subjects | Other | cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. Receives: Device: laser speckle flowgraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging Blood Flow
Imaging blood flow in the tissue is of major importance in the clinical environment
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start23 May 2017
- Primary completion2 Mar 2019
- Study completion2 Mar 2019
Why it stopped: This study was stopped 3/2/18 as the company who supported the device went out of business and requested the device be returned. Only 1 control subject was tested, no analyzable data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randy Kardon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randy Kardon, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660618
- Sponsor's protocol ID
- 201702725
- Status last verified
- May 2023
- First submitted
- 12 Jul 2018
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSFG-SKIN, Laser Speckle Flowgraphy
- ClinicalTrials.gov ID
- NCT03660618
- Acronym / sponsor ID
- 201702725
- Conditions
- Hypertension, Heart Failure, Vascular Ischemia, Burns, Chemotherapy Effect, Radiation Injuries
- Keywords
- perfusion, inflammatory, ischemia, lesions, neuropathy, burns, cancer, stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped 3/2/18 as the company who supported the device went out of business and requested the device be returned. Only 1 control subject was tested, no analyzable data.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Randy KardonUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 10 May 2023
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 project is to quantify normal and abnormal skin blood flow regionally in different areas of the body(face, extremities, over burns and wounds) at baseline and over time in response to treatment or environmental changes, such as temperature, light and pressure.
Detailed description
Laser speckle skin blood flow (LSFG-SKIN) will be recorded in normal subjects and in patients with disorders affecting skin capillary perfusion, which may include cardiovascular disorders, dermatologic disorders, skin wounds, ocular disorders, psychiatric disorders, and neurologic disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinic Subjects | Other | Device: laser speckle flowgraphycardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Controls
- ●Healthy normal control subjects ages 18-90
- Cardiology Subjects
- Ages 18-90
- History of dysrhythmia, heart failure, cardiac ischemia, hypertension, peripheral vascular disease
Key exclusion criteria (24 listed)
- Controls
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- Angle closure glaucoma
- Cardiology Subjects
- Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
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 |
|---|---|---|
| laser speckle flowgraphyblood flow state of the skin as real time two dimensional image | Device | Clinic Subjects |
Primary outcome
Imaging Blood Flow
Time frame: One visit
Imaging blood flow in the tissue is of major importance in the clinical environment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser speckle flowgraphy in people with Hypertension and Heart Failure, run by Randy Kardon 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 23 inclusion and 24 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: stopped early, as of the sponsor's last update on 10 May 2023. 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?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging Blood Flow (time frame: One visit). 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 May 2023.