Measuring Wounds Found on the Outside of the Body Surface

NCT01869439 | Completed Results

• 1 other identifier: WV12CL-0003 Revision 09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 Days

Study Arms (1)

External wounds measured for length by width using a ruler

EXPERIMENTAL

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; 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

Interventions

"gold standard" LxW manual ruler measurement technique DEVICE

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).

External wounds measured for length by width using a ruler

WMMS ImageReview software's LxW measurement technique DEVICE

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).

External wounds measured for length by width using a ruler

WMMS ImageReview software's Visual External Wound Trace DEVICE

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

External wounds measured for length by width using a ruler

WMMS ImageReview software's External Wound Trace Overlay DEVICE

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.

External wounds measured for length by width using a ruler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wound Vision: lead

Study Sites (2)

St. Vincent Seton Specialty Hospital

Indianapolis, Indiana, 46260, United States

Location

St. Vincent Wound Healing Center

Indianapolis, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. James G. Spahn, M.D.
• Organization: WoundVision LLC

brett@woundvision.com

(317) 775-6080

Study Officials

• V. Chowdry Pinnamaneni, M.D.

  St.Vincent Wound Healing Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-10

Locations

US (2)