Early Identification of Suspected Deep Tissue Injury (sDTI)

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02705443

Enrollment

Registered

2016-03-10

Start date

2016-02-29

Completion date

2017-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bed Sore, Pressure Ulcer

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.

Interventions

OTHERNo Intervention

Standard of Care Only

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer	Up to 25 days	Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer
Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer	Up to 25 days	Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer

Secondary

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

Countries

United States

Contacts

Primary ContactNicholas A McMurray, Bachelor

nick@woundvision.com3177756077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026