A Prospective Evaluation of Clinical Equivalence Between iX and PID

MolecuLight Inc.50 enrolled

Overview

Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wound

Interventions

MolecuLight PIDDEVICE

Hand-held, real-time fluorescence imaging device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status 2. 18 years of age or older Exclusion Criteria: 1. Treatment with an investigational drug within 1 month before study enrollment 2. Subjects with recent (\<30 days) biopsy or curettage of target wound 3. Subjects with wounds that cannot be completely imaged by study device due to anatomic location 4. Unable or unwilling to consent

Locations (1)

Judy Dan Research and Treatment Center

North York, Ontario, Canada

Outcomes

Primary Outcomes

Concordance

The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone.

Time frame: 2 months

Secondary Outcomes

Sensitivity and Specificity

Sensitivity and specificity for detection of moderate/heavy bacterial load of PID FL-images to be equal to or greater than that of i:X FL-images when validated by microbiology gold truth

Time frame: 2 months

Data from ClinicalTrials.gov

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