Early Identification of Suspected Deep Tissue Injury (sDTI)

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705443
• Other study ID #: WV15CL-0001
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: November 1, 2016
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: November 2016
• Source: Wound Vision
• Contact: Nicholas A McMurray, Bachelor
• Phone: 3177756077
• Email: nick[@]woundvision.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bed Sore
• Pressure Ulcer

Intervention

Other:
• No Intervention
Standard of Care Only

Locations

Country	Name	City	State
United States	Kindred Hospital Dayton	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wound Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Temperature change associated with anatomical areas after a stageable pressure ulcer occurs		Up to 25 days	No