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

N/ACompletedNCT02028390

Wound Vision31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Wounds and Injuries

Interventions

Scout takes visual and thermal images of external woundsDEVICE

All images are taken after the wound has acclimated.

ImageReview's visual perimeter trace of the external woundDEVICE

Trace is drawn by the study staff using the ImageReview software.

ImageReview's External Wound Trace OverlayDEVICE

Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Integrative Center for Healing

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Study Staff select an unaffected reference area of an adjacent body surface.

Adjacent tissue trace of the wound trace overlayDEVICE

Study staff select an adjacent tissue trace of the wound trace overlay

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented