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Early Identification of Suspected Deep Tissue Injury (sDTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02705443
Recruitment Status : Unknown
Verified November 2016 by Wound Vision.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Wound Vision

Brief Summary:
The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.

Condition or disease Intervention/treatment
Pressure Ulcer Bed Sore Other: No Intervention

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)
Study Start Date : February 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Group/Cohort Intervention/treatment
Tissue w/ Thermographic Anomaly
  • Visibly undamaged tissue with anomaly identified by the thermographic image
  • No intervention
  • Standard of care
Other: No Intervention
Standard of Care Only

Tissue w/o Thermographic Anomaly
  • Visibly undamaged tissue with no anomaly identified by the thermographic image
  • No intervention
  • Standard of care
Other: No Intervention
Standard of Care Only

Tissue w/ Visible Anomaly
  • Visibly damaged tissue
  • No intervention
  • Standard of care
Other: No Intervention
Standard of Care Only




Primary Outcome Measures :
  1. Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer [ Time Frame: Up to 25 days ]
    Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer

  2. Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer [ Time Frame: Up to 25 days ]
    Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer


Secondary Outcome Measures :
  1. Temperature change associated with anatomical areas after a stageable pressure ulcer occurs [ Time Frame: Up to 25 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects admitted to a long-term acute care hospital (LTACH).
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Can tolerate position changes ≥ 10 minutes
  • Non-pregnant

Exclusion Criteria:

  • Therapies/treatments cannot be safely suspended to for an imaging session
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705443


Contacts
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Contact: Nicholas A McMurray, Bachelor 3177756077 nick@woundvision.com

Locations
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United States, Ohio
Kindred Hospital Dayton Recruiting
Dayton, Ohio, United States, 45417
Contact: Richard Simman, M.D.    937-604-7377    Richardsimman@hotmail.com   
Sponsors and Collaborators
Wound Vision
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Responsible Party: Wound Vision
ClinicalTrials.gov Identifier: NCT02705443    
Other Study ID Numbers: WV15CL-0001
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases