Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic

Study Overview
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Brief Summary
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The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.

Official Title
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Scout Overlay-Trace-On-Thermal Feature in a Wound Clinic Setting: A Prospective Study

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Scout takes visual and thermal images of external wounds
* Device: ImageReview's visual perimeter trace of the external wound
* Device: ImageReview's External Wound Trace Overlay
* Device: ImageReview's unaffected reference area selected
* Device: Adjacent tissue trace of the wound trace overlay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or greater, of either gender and of any ethnic background 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: Neonatal and pediatric patients 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subjects with external wounds<br>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. | Device: Scout takes visual and thermal images of external wounds<br>* All images are taken after the wound has acclimated.<br>* Other names: Wound Measuring and Monitoring System/WMMS (past);Device: ImageReview's visual perimeter trace of the external wound<br>* Trace is drawn by the study staff using the ImageReview software.<br>Device: ImageReview's External Wound Trace Overlay<br>* Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.<br>Device: ImageReview's unaffected reference area selected<br>* Study Staff select an unaffected reference area of an adjacent body surface.<br>Device: Adjacent tissue trace of the wound trace overlay<br>* Study staff select an adjacent tissue trace of the wound trace overlay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pixel gradient of the thermal wound surface | Pixel gradient of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Mean pixel value of the thermal wound surface | Mean pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Mode pixel value of the thermal wound surface | Mode pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits at the wound clinic for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Pixel gradient of the thermal unaffected area of body surface selected | Pixel gradient of the the thermal unaffected area of body surface selected will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Highest pixel value of the thermal wound surface | Highest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Lowest pixel value of the thermal wound surface | Lowest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit). | Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit). | Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature | Wound surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 
| Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature | Adjacent tissue trace's surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years. | Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wounds, thermal, temperature, periwound, camera, imaging