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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028390
• Other study ID #: WV13CL-0008 Revision 02
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: November 1, 2016
• Start date: December 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: Wound Vision
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Integrative Center for Healing	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wound Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No