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

Not Applicable

Completed

• Conditions: Wounds and Injuries
• Interventions: 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

• Registration Number: NCT02028390
• Lead Sponsor: Wound Vision

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subjects with external wounds	Scout takes visual and thermal images of 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.
subjects with external wounds	ImageReview's unaffected reference area selected	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.
subjects with external wounds	Adjacent tissue trace of the wound trace overlay	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.
subjects with external wounds	ImageReview's visual perimeter trace of the external wound	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.
subjects with external wounds	ImageReview's External Wound Trace Overlay	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.

Primary Outcome Measures

Name	Time	Method
Mode pixel value of the thermal wound surface	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 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.
Pixel gradient of the thermal unaffected area of body surface selected	Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented	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.
Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature	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'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.
Pixel gradient of the thermal wound surface	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 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.
Mean pixel value of the thermal wound surface	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 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.
Highest pixel value of the thermal wound surface	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 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.
Lowest pixel value of the thermal wound surface	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 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.
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).	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), 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.
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).	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), 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.
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature	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 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.

Trial Locations

Locations (1)

Integrative Center for Healing; 🇺🇸 Cincinnati, Ohio, United States