Decubitus UlcerNCT03034161
Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers
An observational study of Decubitus Ulcer and Pressure Ulcer, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Decubitus Ulcer, Pressure Ulcer
- What is being tested?
- Thermal imaging
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 29 Apr 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sacral/heel pressure ulcers
Who may be able to join
- 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
Who cannot join
- Patients not compliant with obtaining thermal imaging.
- Patients not expected to survive for 48 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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
- Being tested
- Thermal imaging
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage I Pressure Ulcer | Ten patients with a Stage I decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Apr 2019
- Primary completion29 Apr 2019
- Study completion29 Apr 2019 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decubitus UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob T Carlson, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034161
- Sponsor's protocol ID
- 206042
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2017
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers
- ClinicalTrials.gov ID
- NCT03034161
- Acronym / sponsor ID
- 206042
- Conditions
- Decubitus Ulcer, Pressure Ulcer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage I Pressure Ulcer | – | Device: Thermal imagingTen patients with a Stage I decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. |
| Stage II Pressure Ulcer | – | Device: Thermal imagingTen patients with a Stage II decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. |
| Stage III Pressure Ulcer | – | Device: Thermal imagingTen patients with a Stage III decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. |
| Stage IV Pressure Ulcer | – | Device: Thermal imagingTen patients with a Stage IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sacral/heel pressure ulcers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients not compliant with obtaining thermal imaging.
- Patients not expected to survive for 48 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal imagingThermal 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. | Device | Stage I Pressure Ulcer, Stage II Pressure Ulcer, Stage III Pressure Ulcer, Stage IV Pressure Ulcer |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob T Carlson, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decubitus Ulcer and Pressure Ulcer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.