Measuring Wounds Found on the Outside of the Body Surface
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|ClinicalTrials.gov Identifier: NCT01869439|
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
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.)
|Condition or disease||Intervention/treatment||Phase|
|External Wounds Measured for Length by Width Using a Ruler||Device: "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||Not Applicable|
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 by taking simultaneous visual and thermal images of the external wound site and the associated body surface. These images are evaluated by utilizing the WMMS ImageReview measuring and monitoring software. WMMS ImageReview software allows for LxW (length by width) and surface area (cm squared),as well as perimeter (cm) external wound measurements of the visual image. WMMS ImageReview software also allows for the display of thermal intensity variation data for the associated body surface of the corresponding thermal image.
This study is primarily designed to utilize the Coefficients of Individual Agreement (CIA)as a means of establishing the equivalence of area measurements utilizing the WMMS ImageReview software LxW technique and the current "gold standard" LxW manual ruler technique.
A secondary objective measures the thermal intensity variation data of the external wound bed by overlaying the corresponding "Visual External Wound Trace"from the visual image onto the thermal wound bed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utilizing Visual and Thermal Images for the Measuring and Monitoring of External Wounds|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
Experimental: External wounds measured for length by width using a ruler
This is a single arm study of subjects who have an external wound that is currently measured for length and width using a ruler. A study subject may have up to 3 qualifying external wounds.
Device: "gold standard" LxW manual ruler measurement technique
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).
Device: WMMS ImageReview software's LxW measurement technique
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).
Device: WMMS ImageReview software's Visual External Wound Trace
This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.
Device: WMMS ImageReview software's External Wound Trace Overlay
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.
- Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter [ Time Frame: 90 Days ]Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869439
|United States, Indiana|
|St. Vincent Seton Specialty Hospital|
|Indianapolis, Indiana, United States, 46260|
|St. Vincent Wound Healing Center|
|Indianapolis, Indiana, United States, 46260|
|Principal Investigator:||V. Chowdry Pinnamaneni, M.D.||St.Vincent Wound Healing Center|