NCT03660618

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2019

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

July 12, 2018

Results QC Date

May 7, 2019

Last Update Submit

May 9, 2023

Conditions

HypertensionHeart FailureVascular IschemiaBurnsChemotherapy EffectRadiation InjuriesUveitisScleritisMultiple SclerosisAutonomic NeuropathyStrokeIntracranial HemorrhagesTIAMigraineHeadachePain

Keywords

perfusioninflammatoryischemialesionsneuropathyburnscancerstroke

Outcome Measures

Primary Outcomes (1)

  • Imaging Blood Flow

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

    One visit

Study Arms (1)

Clinic Subjects

OTHER

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

Device: laser speckle flowgraphy

Interventions

laser speckle flowgraphyDEVICE

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

Clinic Subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, TIA, multiple sclerosis
  • Psychiatry Subjects
  • +8 more criteria

You may not qualify if:

  • 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
  • \. 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Department of Ophthalmology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

HypertensionHeart FailureBurnsRadiation InjuriesUveitisScleritisMultiple SclerosisStrokeIntracranial HemorrhagesMigraine DisordersHeadachePainIschemiaNeoplasms

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart DiseasesWounds and InjuriesUveal DiseasesEye DiseasesScleral DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersNeurologic ManifestationsSigns and Symptoms

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.

Results Point of Contact

Title
Dr. Randy Kardon
Organization
University of Iowa Healthcare
randy-karon@uiowa.edu
319-356-8299

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology

Study Record Dates

First Submitted

July 12, 2018

First Posted

September 6, 2018

Study Start

May 23, 2017

Primary Completion

March 2, 2019

Study Completion

March 2, 2019

Last Updated

May 10, 2023

Results First Posted

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)