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

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ClinicalTrials.gov Identifier: NCT03034161
Recruitment Status : Withdrawn (lack of funding)
First Posted : January 27, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment
Decubitus Ulcer Pressure Ulcer Device: Thermal imaging

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : April 29, 2019
Estimated Study Completion Date : April 29, 2019

Resource links provided by the National Library of Medicine


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.
Device: 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.

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
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.
Device: 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.

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
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.




Primary Outcome Measures :
  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. [ Time Frame: Up to one year ]
    Each subject will receive one temperature measurement during inpatient status of the decubitus pressure ulcer using the thermal imaging camera.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sacral/heel pressure ulcers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034161


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Jacob T Carlson, MD University of Arkansas

Additional Information:

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03034161     History of Changes
Other Study ID Numbers: 206042
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases