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Early Identification of Suspected Deep Tissue Injury (sDTI)

NCT ID: NCT02705443

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Ulcer Bed Sore

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tissue w/ Thermographic Anomaly

* Visibly undamaged tissue with anomaly identified by the thermographic image
* No intervention
* Standard of care

No Intervention

Intervention Type OTHER

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

No Intervention

Intervention Type OTHER

Standard of Care Only

Tissue w/ Visible Anomaly

* Visibly damaged tissue
* No intervention
* Standard of care

No Intervention

Intervention Type OTHER

Standard of Care Only

Interventions

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No Intervention

Standard of Care Only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wound Vision

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kindred Hospital Dayton

Dayton, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicholas A McMurray, Bachelor

Role: CONTACT

Phone: 3177756077

Email: [email protected]

Facility Contacts

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Richard Simman, M.D.

Role: primary

Other Identifiers

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WV15CL-0001

Identifier Type: -

Identifier Source: org_study_id