Clinical trial NCT02028390: Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic
Official title: Scout Overlay-Trace-On-Thermal Feature in a Wound Clinic Setting: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Keywords: wounds
thermal
temperature
periwound
camera
imaging
Lead sponsor: Wound Vision
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pixel gradient of the thermal wound surface
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Mean pixel value of the thermal wound surface
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Mode pixel value of the thermal wound surface
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Pixel gradient of the thermal unaffected area of body surface selected
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Highest pixel value of the thermal wound surface
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Lowest pixel value of the thermal wound surface
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: 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).
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
measure: Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature
timeFrame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Integrative Center for Healing
state: Ohio
Study officials:
affiliation: Integrative Center for Healing
name: Aletha W. Tippett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: