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Measuring Wounds Found on the Outside of the Body Surface

Primary Purpose

External Wounds Measured for Length by Width Using a Ruler

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

"gold standard" LxW manual ruler measurement technique

WMMS ImageReview software's LxW measurement technique

WMMS ImageReview software's Visual External Wound Trace

WMMS ImageReview software's External Wound Trace Overlay

About this trial

This is an interventional other trial for External Wounds Measured for Length by Width Using a Ruler focused on measuring Pressure Ulcers, Bed Sores, Measuring, Visual Images, Thermal Images, External Wounds, Area, Length, Width, Gradient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 or greater, of either gender and of any ethnic background
Able to tolerate position changes and turns for up to 10 minutes comfortably
Have an existing external wound that is currently measured for length and width using a ruler
- The protocol will allow imaging up to 3 external wounds per subject
- The 3 external wounds must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum).
Have qualifying external wound sites:
- External wounds whose external wound site fits entirely within the field of view and do not wrap around a body edge.
- No device or treatment will obscure the external wound site

Exclusion Criteria:

Neonatal and pediatric patients
Pregnant women
Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site
On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
Have external wound dressing or medical device which cannot or should not be removed as determined by site investigator
Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features
Have complex external wound site(s):
- The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view
- From visual assessment the existing external wound cannot be clearly distinguished from other conditions at the external wound site (e.g. break down or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of wounds makes determining the edge of the external wound impossible)
Have not provided signed informed consent
Non-English speaking

Sites / Locations

St. Vincent Seton Specialty Hospital
St. Vincent Wound Healing Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External wounds measured for length by width using a ruler

Arm 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.

Outcomes

Primary Outcome Measures

Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter

Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.

Secondary Outcome Measures

Full Information

NCT ID

NCT01869439

First Posted

May 22, 2013

Last Updated

October 31, 2017

Sponsor

Wound Vision

1. Study Identification

Unique Protocol Identification Number

NCT01869439

Brief Title

Measuring Wounds Found on the Outside of the Body Surface

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wound Vision

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

External Wounds Measured for Length by Width Using a Ruler

Keywords

Pressure Ulcers, Bed Sores, Measuring, Visual Images, Thermal Images, External Wounds, Area, Length, Width, Gradient

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

External wounds measured for length by width using a ruler

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

"gold standard" LxW manual ruler measurement technique

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

WMMS ImageReview software's LxW measurement technique

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

WMMS ImageReview software's Visual External Wound Trace

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

WMMS ImageReview software's External Wound Trace Overlay

Intervention Description

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.

Primary Outcome Measure Information:

Title

Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter

Description

Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.

Time Frame

90 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 or greater, of either gender and of any ethnic background Able to tolerate position changes and turns for up to 10 minutes comfortably Have an existing external wound that is currently measured for length and width using a ruler The protocol will allow imaging up to 3 external wounds per subject The 3 external wounds must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum). Have qualifying external wound sites: External wounds whose external wound site fits entirely within the field of view and do not wrap around a body edge. No device or treatment will obscure the external wound site Exclusion Criteria: Neonatal and pediatric patients Pregnant women Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged) Cannot be positioned so images can be taken at approximately 90 degrees perpendicular and 18 inches away from the external wound site On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy Have external wound dressing or medical device which cannot or should not be removed as determined by site investigator Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features Have complex external wound site(s): The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view From visual assessment the existing external wound cannot be clearly distinguished from other conditions at the external wound site (e.g. break down or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of wounds makes determining the edge of the external wound impossible) Have not provided signed informed consent Non-English speaking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

V. Chowdry Pinnamaneni, M.D.

Organizational Affiliation

St.Vincent Wound Healing Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Vincent Seton Specialty Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

St. Vincent Wound Healing Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Measuring Wounds Found on the Outside of the Body Surface

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