Status:
COMPLETED
Measuring Wounds Found on the Outside of the Body Surface
Lead Sponsor:
Wound Vision
Conditions:
External Wounds Measured for Length by Width Using a Ruler
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wo...
Detailed Description
This prospective study utilizes the WoundVision Wound Measuring and Monitoring System (WMMS) to study external wounds, which can currently be measured for length by width using a ruler. WMMS operates ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01869439
Start Date
May 1 2013
End Date
December 1 2013
Last Update
December 6 2017
Active Locations (2)
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1
St. Vincent Seton Specialty Hospital
Indianapolis, Indiana, United States, 46260
2
St. Vincent Wound Healing Center
Indianapolis, Indiana, United States, 46260