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

NCT ID: NCT03034161

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-04-29

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.

Detailed Description

This study will be a single-center prospective Phase I study in which the use of a thermal imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. The data collected during this study will be used to determine if stage-specific thermal distribution patterns can be identified. This information will then be used to design future studies in which patients are risk for the development of pressure ulcers are screened for the presence of pressure ulcers not detectable upon physical examination so that preventative measures and treatments can be instituted.

A total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this study. The investigators plan to enroll ten patients with each stage of pressure ulcer (i.e. Stage I-IV), which will provide the investigators with a set of thermal imaging data from which the investigators will determine if thermal distribution patterns unique to each stage of pressure ulcer can be identified. It is anticipated that 40 patients who meet the inclusion criteria and distribution of pressure ulcer staging will be enrolled within one year of the start date of this study.

The investigators are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. It is estimated that the response within each subject group will be normally distributed with standard deviation 25. If the true difference in the experimental and control means is 35, the investigators will need to study 9 experimental subjects and 9 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.

Conditions

Decubitus Ulcer; Pressure Ulcer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Stage I Pressure Ulcer

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

Thermal imaging

Intervention Type: 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 II Pressure Ulcer

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

Thermal imaging

Intervention Type: 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 III Pressure Ulcer

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

Thermal imaging

Intervention Type: 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 IV Pressure Ulcer

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

Thermal imaging

Intervention Type: 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.

Interventions

Thermal imaging

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob T Carlson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

206042

Identifier Type: -

Identifier Source: org_study_id