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Completed

NCT Number: NCT04928235

Utility of Thermal Imaging in Diagnosis of Cellulitis for Lower Extremity Complaints in the Emergency Department

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.

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Key information

Conditions

Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Skin and Subcutaneous Tissue Infection Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin Emergency Department

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal Imaging as Diagnostic Adjunct

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Change in Diagnostic Confidence as Measured by Physician Self-Report

    Time frame: up to one hour

    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.

  2. Diagnostic agreement with expert review panel

    Time frame: 6 months

    Provider cellulitis diagnostic assignment (yes/no) will be compared to an expert panel to determine the rate of concordance.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2021
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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