Early Identification of Suspected Deep Tissue Injury (sDTI)
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 2, 2016
November 1, 2016
1.2 years
March 2, 2016
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer
Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer
Up to 25 days
Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer
Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer
Up to 25 days
Secondary Outcomes (1)
Temperature change associated with anatomical areas after a stageable pressure ulcer occurs
Up to 25 days
Study Arms (3)
Tissue w/ Thermographic Anomaly
* Visibly undamaged tissue with anomaly identified by the thermographic image * No intervention * Standard of care
Tissue w/o Thermographic Anomaly
* Visibly undamaged tissue with no anomaly identified by the thermographic image * No intervention * Standard of care
Tissue w/ Visible Anomaly
* Visibly damaged tissue * No intervention * Standard of care
Interventions
Standard of Care Only
Eligibility Criteria
Subjects admitted to a long-term acute care hospital (LTACH).
You may qualify if:
- years of age or older
- Can tolerate position changes ≥ 10 minutes
- Non-pregnant
You may not qualify if:
- Therapies/treatments cannot be safely suspended to for an imaging session
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wound Visionlead
Study Sites (1)
Kindred Hospital Dayton
Dayton, Ohio, 45417, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2016
First Posted
March 10, 2016
Study Start
February 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
November 2, 2016
Record last verified: 2016-11