Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care

UnknownOBSERVATIONAL
Enrollment

40

Participants

Timeline

Start Date

February 14, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

September 30, 2022

Conditions
Non Healing Diabetic Foot Ulcer
Interventions
DEVICE

MolecuLight i:X Imaging Device

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.

Trial Locations (2)

11042

RECRUITING

Northwell Comprehensive Wound Healing Center and Hyperbarics, Lake Success

92083

RECRUITING

ILD Research Centre, Vista

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MolecuLight Inc.

INDUSTRY

NCT04207099 - Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care | Biotech Hunter | Biotech Hunter