Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers

NCT03034161 | Withdrawn

• 1 other identifier: 206042
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.

Conditions

Decubitus Ulcer; Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Difference in temperature between a Stage I, Stage 2, Stage 3 and Stage 4 decubitus pressure ulcer as measured by using the thermal imaging camera.

  Each subject will receive one temperature measurement during inpatient status of the decubitus pressure ulcer using the thermal imaging camera.

  Up to one year

Study Arms (4)

Stage I Pressure Ulcer

Ten patients with a Stage I decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.

Device: Thermal imaging

Stage II Pressure Ulcer

Ten patients with a Stage II decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.

Device: Thermal imaging

Stage III Pressure Ulcer

Ten patients with a Stage III decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.

Device: Thermal imaging

Stage IV Pressure Ulcer

Ten patients with a Stage IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera.

Device: Thermal imaging

Interventions

Thermal imaging DEVICE

Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.

Stage I Pressure Ulcer; Stage II Pressure Ulcer; Stage III Pressure Ulcer; Stage IV Pressure Ulcer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sacral/heel pressure ulcers

You may qualify if:

• Patients with sacral/heel pressure ulcers, admitted to University of Arkansas for Medical Sciences (UAMS) inpatient services.
• Patients 18-years old or older.
• Patients have an expected survival of \> 48 hours

You may not qualify if:

• Patients not compliant with obtaining thermal imaging.
• Patients not expected to survive for 48 hours.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacob T Carlson, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: April 1, 2019
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

US (1)