CellulitisNCT04928235
Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
An observational study of Cellulitis and Skin and Subcutaneous Tissue Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis, Skin and Subcutaneous Tissue Infection
- What is being tested?
- Thermal Imaging as Diagnostic Adjunct
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2021to 18 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Seeking to include all patients who present to the Emergency Department for a skin related, acute lower extremity complaint and able to provide informed consent.
Who may be able to join
- Participant is presenting to the University of Wisconsin Emergency Department
- Participant has an acute skin complaint on the lower extremity
Who cannot join
- Participant is has limited English and Spanish proficiency
- There was an acute traumatic injury of affected area in last 5 days- includes burns
- Affected area has a confirmed fracture
- Participant is pregnant
- Participant is a prisoner
- Current complaint is in an area of past surgical procedure (within past 4 weeks)
Show all 10Show fewer
- Participant has implant or hardware at site
- Animal or human bite is cause of complaint
- Temperature of the leg has been altered in the last one hour
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Emergency Department
Madison, Wisconsin, 53705
About this study
The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation.
Read the detailed description
Previous literature estimates the emergency department misdiagnosis rate for cellulitis exceeds 30% due to conditions which can mimic cellulitis (termed pseudocellulitis). These diagnostic errors are associated with an estimated $195 to $515 million dollars in avoidable healthcare spending each year. Objective skin surface temperature measurement, obtained via thermal imaging cameras, has been proposed as a diagnostic adjunct that may reduce diagnostic error in cases of suspected cellulitis. One recent study, identified that the maximum affected skin temperature in cellulitis is significantly higher than in pseudocellulitis, and the temperature gradient between affected and unaffected sites in patients with cellulitis is significantly higher than in patients with pseudocellulitis.
The overall purpose of the study is to determine how providing physicians with a quantifiable measure of skin surface temperature information influences diagnoses and diagnostic confidence in potential cellulitis cases when added to standard physical exam techniques
The Aims of the study are to :
Specific Aim 1: To characterize the temperature difference between affected and unaffected limbs in patients with cellulitis in the emergency department.
Specific Aim 2: To characterize the temperature difference between cases of cellulitis and pseudocellulitis
Specific Aim 3: To determine how quantifying temperature gradients changes diagnostic confidence and accuracy when added to the standard diagnostic evaluation for potential cellulitis.
The investigators will prospectively enroll a maximum of 560 patients with non-traumatic lower extremity dermatologic complaints with visible erythema (potential cellulitis) in the University of Wisconsin Emergency Department. A thermal image and a photograph of the affected and the unaffected limbs will be taken.
- Conditions
- Cellulitis, Skin and Subcutaneous Tissue Infection
- Being tested
- Thermal Imaging as Diagnostic Adjunct
- Keywords
- Diagnostic confidence, Diagnostic accuracy, Diagnostic error
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Imaging as Diagnostic AdjunctDiagnostic test
Thermal images of the participants lower extremities will be taken and skin surface temperature values will be provided to the healthcare provider for review during the emergency department encounter.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All participants will have thermal imaging of their lower extremities. The temperature values will be shared with the attending physician. The physician will be asked questions about their diagnostic confidence before and after seeing the temperature values. Receives: Diagnostic Test: Thermal Imaging as Diagnostic Adjunct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis
Differences in skin surface temperatures of affected and unaffected areas for those with a final diagnosis of cellulitis.
Measured: up to one hour
Skin Temperature Difference Between Participants Diagnosed with Pseudocellulitis and Cellulitis
Determine differences in skin surface temperatures between cases of pseudocellulitis and cellulitis (on the affected legs).
Measured: up to one hour
Secondary outcomes (2)
Change in Diagnostic Confidence as Measured by Physician Self-Report
Comparison of the change in diagnostic confidence as measured by the attending physician response pre/post thermal imaging review. This was a question developed by the study team and response options include not at all confident, slightly confident, somewhat confident, very confident, extremely confident. No number values are assigned to response values as of yet.
Measured: up to one hour
Diagnostic agreement with expert review panel
Provider cellulitis diagnostic assignment (yes/no) will be compared to an expert panel to determine the rate of concordance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start18 Jul 2021
- Primary completion18 Jan 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Michael Pulia, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928235
- Sponsor's protocol ID
- 2018-0823 Phase 2
- Other IDs
- A534100, SMPH/EMERG MED, 1K08HS024342-01A1
- Status last verified
- Dec 2023
- First submitted
- 9 Jun 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department
- ClinicalTrials.gov ID
- NCT04928235
- Acronym / sponsor ID
- 2018-0823 Phase 2
- Conditions
- Cellulitis, Skin and Subcutaneous Tissue Infection
- Keywords
- Diagnostic confidence, Diagnostic accuracy, Diagnostic error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- 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.
The overall purpose of the study is to determine how providing physicians with a quantitative measure of skin surface temperature influences diagnoses and diagnostic confidence in potential cellulitis cases when added to the standard evaluation.
Detailed description
Previous literature estimates the emergency department misdiagnosis rate for cellulitis exceeds 30% due to conditions which can mimic cellulitis (termed pseudocellulitis). These diagnostic errors are associated with an estimated $195 to $515 million dollars in avoidable healthcare spending each year. Objective skin surface temperature measurement, obtained via thermal imaging cameras, has been proposed as a diagnostic adjunct that may reduce diagnostic error in cases of suspected cellulitis. One recent study, identified that the maximum affected skin temperature in cellulitis is significantly higher than in pseudocellulitis, and the temperature gradient between affected and unaffected sites in patients with cellulitis is significantly higher than in patients with pseudocellulitis.
The overall purpose of the study is to determine how providing physicians with a quantifiable measure of skin surface temperature information influences diagnoses and diagnostic confidence in potential cellulitis cases when added to standard physical exam techniques
The Aims of the study are to :
Specific Aim 1: To characterize the temperature difference between affected and unaffected limbs in patients with cellulitis in the emergency department.
Specific Aim 2: To characterize the temperature difference between cases of cellulitis and pseudocellulitis
Specific Aim 3: To determine how quantifying temperature gradients changes diagnostic confidence and accuracy when added to the standard diagnostic evaluation for potential cellulitis.
The investigators will prospectively enroll a maximum of 560 patients with non-traumatic lower extremity dermatologic complaints with visible erythema (potential cellulitis) in the University of Wisconsin Emergency Department. A thermal image and a photograph of the affected and the unaffected limbs will be taken.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Thermal Imaging as Diagnostic AdjunctAll participants will have thermal imaging of their lower extremities. The temperature values will be shared with the attending physician. The physician will be asked questions about their diagnostic confidence before and after seeing the temperature values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seeking to include all patients who present to the Emergency Department for a skin related, acute lower extremity complaint and able to provide informed consent.
Key inclusion criteria (2 listed)
- Participant is presenting to the University of Wisconsin Emergency Department
- Participant has an acute skin complaint on the lower extremity
Key exclusion criteria (10 listed)
- Participant is has limited English and Spanish proficiency
- There was an acute traumatic injury of affected area in last 5 days- includes burns
- Affected area has a confirmed fracture
- Participant is pregnant
- Participant is a prisoner
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 Imaging as Diagnostic AdjunctThermal images of the participants lower extremities will be taken and skin surface temperature values will be provided to the healthcare provider for review during the emergency department encounter. | Diagnostic test | All Participants |
Primary outcome
Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis
Time frame: up to one hour
Differences in skin surface temperatures of affected and unaffected areas for those with a final diagnosis of cellulitis.
Skin Temperature Difference Between Participants Diagnosed with Pseudocellulitis and Cellulitis
Time frame: up to one hour
Determine differences in skin surface temperatures between cases of pseudocellulitis and cellulitis (on the affected legs).
2 secondary outcomes
Change in Diagnostic Confidence as Measured by Physician Self-Report
Time frame: up to one hour
Diagnostic agreement with expert review panel
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Michael Pulia, MD, MS principal investigator
University of Wisconsin, Madison
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 Cellulitis and Skin and Subcutaneous Tissue Infection, run by University of Wisconsin, Madison 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 7 Dec 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin Temperature Difference Between Affected and Unaffected Legs for Participants with Cellulitis (time frame: up to one hour). The study lists 2 primary outcomes in all. 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 7 Dec 2023.