RecruitingNCT06682923
MolecuLightDX Measurement Feature Clinical Validation
Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
Sponsor
MolecuLight Inc.
Enrollment
72 participants
Start Date
Oct 23, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.
Eligibility
Min Age: 22 Years
Inclusion Criteria6
- Willing to consent
- Willing to comply with all study procedures and availability for the duration of the study
- Male or female, aged over 22 years old
- Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
- Wound size is greater than 0.5 cm2
- The wound has well-defined wound borders
Exclusion Criteria6
- Circumferential wound
- Wound without clearly defined wound borders
- Wound located in a difficult to reach/measure location
- Any contra-indication to routine wound care and/or monitoring
- Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
- Tunneled or undermined wounds
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Interventions
DEVICEMolecuLight DX Imaging Device
The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06682923
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