Pressure UlcersNCT00664235
The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury
An observational study of Pressure Ulcers and Tissue Injury, run by Trillennium Medical Imaging, Inc. at 1 site in United States.
Trial summary
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers, Tissue Injury
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be recruited from Duke North inpatient unit 8100 or 8300. All patients admitted to the above floor will be evaluated for willingness to participate.
Who may be able to join
- To be admitted to 8100 or 8300 and be willing to participate in the study
Who cannot join
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
David W. Judy, D.O., 919-668-0145, david.judy@duke.edu
Claude S. Burton, M.D.
About this study
Official title: Study of Thermal Imaging as an Objective RISK Indicator; The Evaluation of Skin Blood Flow and Temperature by Long Wave Infra-Red Imaging to Determine Effectiveness as a Predictor of Pressure Ulcer or Non-Visible Deep Tissue Damage
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.
Read the detailed description
The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.
Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.
All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.
- Conditions
- Pressure Ulcers, Tissue Injury
- Keywords
- Pressure Ulcers, Tissue Injury
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Each time a pattern of injury is identified by the device, we will correlate this occurrence with the Braden scale to see whether or not it suggested an injury potential.
Measured: 90 days
Secondary outcomes (1)
It is our hypothesis that the pattern of injury will develop without warning from the Braden scores.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trillennium Medical Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claude S. Burton, M.D., Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664235
- Sponsor's protocol ID
- Pro00003228
- Status last verified
- Apr 2008
- First submitted
- 21 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thermal Imaging as an Objective RISK Indicator; The Evaluation of Skin Blood Flow and Temperature by Long Wave Infra-Red Imaging to Determine Effectiveness as a Predictor of Pressure Ulcer or Non-Visible Deep Tissue Damage
- ClinicalTrials.gov ID
- NCT00664235
- Acronym / sponsor ID
- Pro00003228
- Conditions
- Pressure Ulcers, Tissue Injury
- Keywords
- Pressure Ulcers, Tissue Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trillennium Medical Imaging, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 22 Apr 2008 (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.
Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.
Detailed description
The Trillennium Medical Imaging system will be used to gather skin temperature data on 100 subjects. The subjects will be enrolled from Duke North floors 8100 or 8300 in a prospective controlled trial. All eligible patients who have signed a consent form will be assessed using the Long Wave Infrared imaging.
Subjects eligible for this study who have signed a consent form will be scanned on bilateral heels and sacrum. Subjects with ulcers on those areas will also be scanned due to the fact that they are at a high risk of developing additional pressure ulcers. The intent is not to capture images of the existing ulcer, but to focus on areas that could potentially develop into additional pressure ulcers. The subjects who already have an ulcer will only be scanned on non ulcerated tissue. The areas of interest must be off-loaded for 3 minutes from any pressure in order to acclimate to ambient temperature. The device will be held approximately 36 inches from the area of interest in order to obtain an image. The subjects will be assessed within 24 hours of admission and every 24 hours until discharge or they develop a pressure ulcer. The subject's routinely recorded Braden scores (By on the floor nursing staff) will also be captured in order to effectively compare the effectiveness of the Imaging system. The nurse conducting the imaging will also record a Braden score.
All subjects will be included in the trial unless they refuse to participate or are incapacitated to the degree that imaging becomes unreasonable.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from Duke North inpatient unit 8100 or 8300. All patients admitted to the above floor will be evaluated for willingness to participate.
Key inclusion criteria (1 listed)
- To be admitted to 8100 or 8300 and be willing to participate in the study
Key exclusion criteria (1 listed)
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Each time a pattern of injury is identified by the device, we will correlate this occurrence with the Braden scale to see whether or not it suggested an injury potential.
Time frame: 90 days
1 secondary outcome
It is our hypothesis that the pattern of injury will develop without warning from the Braden scores.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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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.
Claude S. Burton, M.D. principal investigator
Duke Health
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 Pressure Ulcers and Tissue Injury, run by Trillennium Medical Imaging, Inc. 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Apr 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David W Judy, D.O. (919-668-0145, david.judy@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Each time a pattern of injury is identified by the device, we will correlate this occurrence with the Braden scale to see whether or not it suggested an injury potential. (time frame: 90 days). 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 22 Apr 2008.