Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
- Conditions
- Wound
- Registration Number
- NCT03540004
- Lead Sponsor
- MolecuLight Inc.
- Brief Summary
This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 367
- Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
- 18 years or older
- Treatment with an investigational drug within 1 month before study enrolment
- Subjects with recent (<30 days) biopsy of target wound
- Subjects with wounds that cannot be completely imaged by study device due to anatomic location
- Inability to consent
- Any contra-indication to routine wound care and/or monitoring
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity. 1 year Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load
Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load
- Secondary Outcome Measures
Name Time Method Estimation of sensitivity and specificity of MolecuLight i:X alone 1.5 years
Trial Locations
- Locations (14)
Cleveland Foot and Ankle Clinic
🇺🇸Cleveland, Ohio, United States
Martin Foot and Ankle
🇺🇸York, Pennsylvania, United States
Foot and Ankle Center
🇺🇸Bryn Mawr, Pennsylvania, United States
El Campo Memorial Hospital
🇺🇸El Campo, Texas, United States
New Hope Podiatry Group
🇺🇸Los Angeles, California, United States
The Wound Treatment Center at Opelousas General Health System
🇺🇸Opelousas, Louisiana, United States
Royal Research Group
🇺🇸Pembroke Pines, Florida, United States
Saint Mary's Center for Wound Healing
🇺🇸Athens, Georgia, United States
The Foot and Ankle Wellness Center of Western Pennsylvania
🇺🇸Ford City, Pennsylvania, United States
The Heal Clinic
🇺🇸Tulsa, Oklahoma, United States
Armstrong County Memorial Hospital
🇺🇸Kittanning, Pennsylvania, United States
Texas Gulf Coast Medical Group
🇺🇸Houston, Texas, United States
Saint Vincent Health Center
🇺🇸Erie, Pennsylvania, United States
Serena Group Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States