ClinicalTrials.gg
TerminatedNCT03660618Updated May 10, 2023Results posted

LSFG-SKIN, Laser Speckle Flowgraphy

An interventional study of laser speckle flowgraphy in Hypertension, Heart Failure and Vascular Ischemia, sponsored by Randy Kardon. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by Randy Kardon · Not applicable, Interventional, and Treatment

Why this study was terminated
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.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2017, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension
  • Heart Failure
  • Vascular Ischemia
  • Burns
  • Chemotherapy Effect
  • Radiation Injuries
  • Uveitis
  • Scleritis
  • Multiple Sclerosis
  • Autonomic Neuropathy
  • Stroke
  • Intracranial Hemorrhages
  • TIA
  • Migraine
  • Headache
  • Pain

Keywords

  • perfusion
  • inflammatory
  • ischemia
  • lesions
  • neuropathy
  • burns
  • cancer
  • stroke
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 1 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Randy Kardon is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

  • 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, , 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

Exclusion criteria

Exclusion Criteria:

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

    1. 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Other
    Clinic Subjects

    cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects.

    Device: laser speckle flowgraphy

Interventions

  • Devicelaser speckle flowgraphy

    blood flow state of the skin as real time two dimensional image

06

What researchers measure

Primary outcomes

  1. Imaging Blood Flow

    Imaging blood flow in the tissue is of major importance in the clinical environment

    Time frame: One visit

07

Results

Posted May 10, 2023
Limitations and caveats
Early termination due to company going out of business, requested device be returned. No other companies supported this type of device. Early termination lead to only 1 subject enrolled, no analyzable data.

Participant flow

Participant flow — Overall Study
MilestoneClinic Subjects
Started1
Completed1
Not completed0

Outcome measures

PrimaryImaging Blood Flow

Imaging blood flow in the tissue is of major importance in the clinical environment

Time frame:
One visit

No measurements were reported for this outcome.

Adverse events

Collected over 1 year, 5 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Clinic Subjects0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

female

Age, Continuous
Age, Continuous(years)Clinic Subjects
Mean55
Sex: Female, Male
Sex: Female, Male(Participants)Clinic Subjects
Female1
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Clinic Subjects
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White1
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • University of Iowa Department of Ophthalmology
    Iowa City, Iowa 52242, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Mar 2019, 21 months.

Results were first posted in May 2023, 4 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2018
First posted
Sep 6, 2018
StartActual
May 23, 2017
Primary completionActual
Mar 2, 2019
CompletionActual
Mar 2, 2019
Results first posted
May 10, 2023
Last update
May 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03660618
Lead sponsor
Randy Kardon
Responsible party
Randy Kardon (Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology, University of Iowa) — Sponsor-investigator
First posted
Sep 6, 2018
Start date
May 23, 2017
Primary completion
Mar 2, 2019
Completion
Mar 2, 2019
Results posted
May 10, 2023
Last update
May 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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