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

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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Integrative Center for Healing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Scout takes visual and thermal images of external wounds; All images are taken after the wound has acclimated.; Other Names: Wound Measuring and Monitoring System/WMMS (past); Device: ImageReview's visual perimeter trace of the external wound; Trace is drawn by the study staff using the ImageReview software.; Device: 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.; Device: ImageReview's unaffected reference area selected; Study Staff select an unaffected reference area of an adjacent body surface.; Device: Adjacent tissue trace of the wound trace overlay; Study staff select an adjacent tissue trace of the wound trace overlay

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wound Vision
• Investigators: Principal Investigator: Aletha W. Tippett, M.D., Integrative Center for Healing

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 3, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: imaging; thermal; temperature; wounds; camera; periwound
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: WV13CL-0008 Revision 02