A Prospective Evaluation of Clinical Equivalence Between iX and PID

MolecuLight

Status: Unknown

Conditions: Wound

Treatments: Device: MolecuLight PID

Study type: Observational

Funder types: Industry

Identifiers

NCT03967405

19-002 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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