NCT01869439

Measuring Wounds Found on the Outside of the Body Surface

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wound Vision · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.)

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 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.

Conditions

• External Wounds Measured for Length by Width Using a Ruler

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2013-06-05
• Last updated: 2017-12-06
• Results posted: 2017-12-06

Locations

2 sites across 1 country: United States