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Trial record 4 of 80602 for:    measured

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
Sponsor:
Information provided by (Responsible Party):
Wound Vision

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition External Wounds Measured for Length by Width Using a Ruler
Interventions 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
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wounds Measures of LxW Ruler & Software LxW, Area & Perimeter
Hide Arm/Group Description

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.

"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).

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).

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.

Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title External Wounds Measured for Length by Width Using a Ruler
Hide Arm/Group Description

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.

"gold standard" LxW manual ruler measurement technique: The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length).

LxW measurement technique: This software measurement technique measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).

Visual External Wound Trace: This software measurement enables the user to trace the perimeter edge of the wound's visual image.

External Wound Trace Overlay: This software measurement utilizes the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, data such as the differences in the thermal intensities (gradiency), mean, and the mode of the thermal wound bed can be measured.

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>18 years Number Analyzed 40 participants
40
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
20
  50.0%
Male
20
  50.0%
1.Primary Outcome
Title Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter
Hide Description Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
40 wounds captured in an inpatient and outpatient population.
Arm/Group Title Wounds Measured for Length by Width Using a Ruler and Software
Hide Arm/Group Description:

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.

The "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).

Software 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).

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.

Overall Number of Participants Analyzed 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of CV
Between Reader Software LxW Area
20.07
(16.71%)
Between Reader Software Trace Area
16.28
(16.10%)
Between Reader Software Perimeter
16.28
(5.82%)
Within Reader Software Trace Area
20.07
(8.68%)
Within Reader Area by Software Measurement
16.28
(6.46%)
Within Reader Software Perimeter
16.28
(3.32%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title External Wounds Measured for Length by Width Using a Ruler
Hide Arm/Group Description

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.

"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).

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).

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.

All-Cause Mortality
External Wounds Measured for Length by Width Using a Ruler
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
External Wounds Measured for Length by Width Using a Ruler
Affected / at Risk (%)
Total   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
External Wounds Measured for Length by Width Using a Ruler
Affected / at Risk (%)
Total   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James G. Spahn, M.D.
Organization: WoundVision LLC
Phone: (317) 775-6080
EMail: brett@woundvision.com
Layout table for additonal information
Responsible Party: Wound Vision
ClinicalTrials.gov Identifier: NCT01869439     History of Changes
Other Study ID Numbers: WV12CL-0003 Revision 09
First Submitted: May 22, 2013
First Posted: June 5, 2013
Results First Submitted: November 1, 2016
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017