- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03034161
Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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.
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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.
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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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Up to one year
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Each subject will receive one temperature measurement during inpatient status of the decubitus pressure ulcer using the thermal imaging camera.
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Up to one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacob T Carlson, MD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 206042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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