Early Identification of Suspected Deep Tissue Injury (sDTI)

Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer; Bed Sore
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Recruiting
      • Kindred Hospital Dayton
      • Contact: Richard Simman, M.D.; Phone Number: 937-604-7377; Email: Richardsimman@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects admitted to a long-term acute care hospital (LTACH).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Temperature change associated with anatomical areas after a stageable pressure ulcer occurs	Up to 25 days

Collaborators and Investigators

• Sponsor: Wound Vision

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: WV15CL-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED