CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
"gold standard" LxW manual ruler measurement technique +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01869439
NCT01869439N/ACompleted

Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds

Wound Vision·interventional·Posted Jun 5, 2013·Updated Dec 6, 2017

In Brief

A clinical study evaluating "gold standard" LxW manual ruler measurement technique, WMMS ImageReview software's LxW measurement technique, and 2 other interventions for External Wounds Measured for Length by Width Using a Ruler. Completed, enrolled 40 participants across 2 sites.

Detailed 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.)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2013
Enrollment StartMay 1, 2013
Primary CompletionJun 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.1 years ago

Interventions

"gold standard" LxW manual ruler measurement techniquedevice

Currently, the "gold standard" LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).

WMMS ImageReview software's LxW measurement techniquedevice

This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).

WMMS ImageReview software's Visual External Wound Tracedevice

This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.

WMMS ImageReview software's External Wound Trace Overlaydevice

This measurement technique is a feature of the WMMS, utilizing the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, variation data such as the differences in the thermal intensities (gradient), mean, and the mode of the thermal wound bed can be measured.