Measuring Wounds Found on the Outside of the Body Surface

Completed · Not applicable

Conditions studied: External Wounds Measured for Length by Width Using a Ruler

In brief

The purpose of this study is to test wounds found on the outside of the body surface with an investigational medical imaging device that collects visual pictures and thermal digital pictures of the wound site. The investigational device has not been approved by the Food and Drug Administration (FDA). The medical imaging device is non-contacting and is non-radiating (delivers no energy to the body). It passively collects pictures (typical digital color photographs)and thermal pictures (black and white digital photographs of heat at the body surface.)

Key facts

Study ID

NCT01869439

Run by

Wound Vision

People needed

40

Starts

2013-05-01

Expected to finish

2013-12-01

Last updated by the study team

2017-12-06

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 changes and turns for up to 10 minutes comfortably
• Have an existing external wound that is currently measured for length and width using a ruler
• The protocol will allow imaging up to 3 external wounds per subject
• The 3 external wounds 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 sites:
• External wounds whose external wound site fits entirely within the field of view and do not wrap around a body edge.
• No device or treatment will obscure the external wound site

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)
• Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site
• On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
• Have external 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
• Have complex external wound site(s):
• The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view
• From visual assessment the existing external wound cannot be clearly distinguished from other conditions at the external wound site (e.g. break down or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of wounds makes determining the edge of the external wound impossible)
• Have not provided signed informed consent
• Non-English speaking

Where it is running

• St. Vincent Seton Specialty Hospital — Indianapolis, Indiana, United States
• St. Vincent Wound Healing Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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