This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. One arm receives i:X guided treatment and the other arm receives standard of care treatment. Our primary objective is to compare the wound area reduction in both arms.
Study Type
OBSERVATIONAL
Enrollment
40
The MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
ILD Research Centre
Vista, California, United States
RECRUITINGNorthwell Comprehensive Wound Healing Center and Hyperbarics
Lake Success, New York, United States
RECRUITINGRate of change in wound area of diabetic foot ulcers in ARM 2 vs ARM 1
ARM 2 vs ARM 1 Evaluate change in wound area over 12-week period
Time frame: 5 months
Wound Healing Rate
ARM 1 vs. ARM 2 1. Evaluate increase in wound healing rate over 12-week period 2. Evaluate differences in clinical infection i. time to eradicate an infection ii. incidence of new infection (i.e. infection avoidance) 3. Determine if MolecuLight i:X images taken at baseline can predict non-healing wounds, region for debridement and/or wounds at risk of infection (based on fluorescent signatures) at 6 and 12 weeks.
Time frame: 5 months
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