N/A N=40 Other

Measuring Wounds Found on the Outside of the Body Surface

External Wounds Measured for Length by Width Using a Ruler

Bottom Line

View on ClinicalTrials.gov: NCT01869439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter — 20.07; 16.28; 16.28; 20.07 percentage of CV

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: "gold standard" LxW manual ruler measurement technique (Device); WMMS ImageReview software's LxW measurement technique (Device); WMMS ImageReview software's Visual External Wound Trace (Device); WMMS ImageReview software's External Wound Trace Overlay (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wound Vision
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter	20.07; 16.28; 16.28; 20.07; 16.28; 16.28	—

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 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.)

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01869439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.