Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic
NCT ID: NCT02028390
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2013-12-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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subjects with external wounds
Subjects with external wounds or body surface areas of interest are imaged visually and thermally with the Scout to trace the wound's perimeter visually and measure thermal variation data as described in the primary outcomes, using the ImageReview software.
Scout takes visual and thermal images of external wounds
All images are taken after the wound has acclimated.
ImageReview's visual perimeter trace of the external wound
Trace is drawn by the study staff using the ImageReview software.
ImageReview's External Wound Trace Overlay
Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.
ImageReview's unaffected reference area selected
Study Staff select an unaffected reference area of an adjacent body surface.
Adjacent tissue trace of the wound trace overlay
Study staff select an adjacent tissue trace of the wound trace overlay
Interventions
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Scout takes visual and thermal images of external wounds
All images are taken after the wound has acclimated.
ImageReview's visual perimeter trace of the external wound
Trace is drawn by the study staff using the ImageReview software.
ImageReview's External Wound Trace Overlay
Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.
ImageReview's unaffected reference area selected
Study Staff select an unaffected reference area of an adjacent body surface.
Adjacent tissue trace of the wound trace overlay
Study staff select an adjacent tissue trace of the wound trace overlay
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to tolerate position change(s) and turns for up to 10 minutes comfortably
* Have an existing external wound or body surface area of interest:
* External wound or body surface area of interest must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum)
* Have qualifying external wound or body surface area of interest:
* External wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge
* No device or treatment will obscure the external wound or body surface area of interest
Exclusion Criteria
* Pregnant women
* Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
* On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
* Have a wound dressing or medical device which cannot or should not be removed as determined by site investigator
* Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features.
* If the patient has a complex external wound:
* The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view.
* From visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (E.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible).
* Have not provided signed informed consent
* Non-English speaking
* Subjects in isolation
18 Years
ALL
No
Sponsors
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Wound Vision
INDUSTRY
Responsible Party
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Principal Investigators
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Aletha W. Tippett, M.D.
Role: PRINCIPAL_INVESTIGATOR
Integrative Center for Healing
Locations
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Integrative Center for Healing
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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WV13CL-0008 Revision 02
Identifier Type: -
Identifier Source: org_study_id