Skip to main content
OpenTrials
Completed

NCT Number: NCT02028390

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Center for Healing

Cincinnati, Ohio, 45242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scout takes visual and thermal images of external wounds

Device

All images are taken after the wound has acclimated.

Other names: Wound Measuring and Monitoring System/WMMS (past)

ImageReview's visual perimeter trace of the external wound

Device

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

ImageReview's External Wound Trace Overlay

Device

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

Device

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

Adjacent tissue trace of the wound trace overlay

Device

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

Primary outcomes

  1. Pixel gradient of the thermal wound surface

    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 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.

  2. Mean pixel value of the thermal wound surface

    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 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.

  3. Mode pixel value of the thermal wound surface

    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 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.

  4. Pixel gradient of the thermal unaffected area of body surface selected

    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 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.

  5. Highest pixel value of the thermal wound surface

    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 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.

  6. Lowest pixel value of the thermal wound surface

    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 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.

  7. 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).

    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.

  8. Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).

    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), 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.

  9. Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature

    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 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.

  10. Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature

    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'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.

Sponsors and collaborators

Lead sponsor

Wound Vision

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 7, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.