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

Completed · Not applicable

Conditions studied: Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT02028390

Run by

Wound Vision

People needed

31

Starts

2013-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Integrative Center for Healing — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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