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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic Subjects | Other | cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser speckle flowgraphy | Device | blood flow state of the skin as real time two dimensional image |
|
| Measure | Description | Time Frame |
|---|---|---|
| Imaging Blood Flow | Imaging blood flow in the tissue is of major importance in the clinical environment | One visit |
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Inclusion Criteria:
Controls
●Healthy normal control subjects ages 18-90
Cardiology Subjects
Dermatology Subjects
Endocrine Subjects
Neurology Subjects
Psychiatry Subjects
Surgery Subjects
Ophthalmology Subjects
Exclusion Criteria:
Controls
Cardiology Subjects
Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
Angle closure glaucoma
3. Dermatology Subjects
Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
Angle closure glaucoma
Endocrine Subjects
Neurology Subjects
Psychiatry Subjects
Surgery Subjects
Ophthalmology Subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Department of Ophthalmology | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinic Subjects | cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. laser speckle flowgraphy: blood flow state of the skin as real time two dimensional image |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
female
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinic Subjects | cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. laser speckle flowgraphy: blood flow state of the skin as real time two dimensional image |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Imaging Blood Flow | Imaging blood flow in the tissue is of major importance in the clinical environment | One subject tested before device had to be returned due to company going out of business. Data was not measurable and no repeat testing was possible as device was returned. | Posted | One visit |
|
|
1 year, 5 months.
No adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinic Subjects | cardiology subjects, dermatology subjects, endocrine subjects, neurology subjects, psychiatry subjects, surgery subjects, ophthalmology subjects. laser speckle flowgraphy: blood flow state of the skin as real time two dimensional image |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Randy Kardon | University of Iowa Healthcare | 319-356-8299 | randy-karon@uiowa.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2019 | Jun 22, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006333 | Heart Failure |
| D002056 | Burns |
| D011832 | Radiation Injuries |
| D014605 | Uveitis |
| D015423 | Scleritis |
| D009103 | Multiple Sclerosis |
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D010146 | Pain |
| D007511 | Ischemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D014947 | Wounds and Injuries |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D014603 |
| Uveal Diseases |
| D005128 | Eye Diseases |
| D015422 | Scleral Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |