NCT04928235

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

June 9, 2021

Last Update Submit

December 5, 2023

Conditions

CellulitisSkin and Subcutaneous Tissue Infection

Keywords

Diagnostic confidenceDiagnostic accuracyDiagnostic error

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in Diagnostic Confidence as Measured by Physician Self-Report

    up to one hour

  • Diagnostic agreement with expert review panel

    6 months

Study Arms (1)

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.

Diagnostic Test: Thermal Imaging as Diagnostic Adjunct

Interventions

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.

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Participant is presenting to the University of Wisconsin Emergency Department
  • Participant has an acute skin complaint on the lower extremity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Emergency Department

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Pulia, MD, MS

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

July 18, 2021

Primary Completion

January 18, 2023

Study Completion

February 18, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)