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Measuring Wounds Found on the Outside of the Body Surface

NCT01869439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-06

Study results available
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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.)

Conditions

  • External Wounds Measured for Length by Width Using a Ruler

Interventions

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.

Sponsors & Collaborators

  • Wound Vision

    lead INDUSTRY

Principal Investigators

  • V. Chowdry Pinnamaneni, M.D. · St.Vincent Wound Healing Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869439 on ClinicalTrials.gov