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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04928235
Other study ID # 2018-0823 Phase 2
Secondary ID A534100SMPH/EMER
Status Completed
Phase
First received
Last updated
Start date July 18, 2021
Est. completion date February 18, 2023

Study information

Verified date December 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 416
Est. completion date February 18, 2023
Est. primary completion date January 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant is presenting to the University of Wisconsin Emergency Department - Participant has an acute skin complaint on the lower extremity Exclusion Criteria: - 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) - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Thermal Imaging as Diagnostic Adjunct
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.

Locations

Country Name City State
United States University of Wisconsin Emergency Department Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to one hour
Primary 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). up to one hour
Secondary 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. up to one hour
Secondary 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. 6 months
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