Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care
Sponsor: MolecuLight Inc.
Summary
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.
Official title: A 12-week, Prospective, Parallel Arm, Randomized Controlled Trial (RCT) Comparing Wound Area Reduction of Non-healing Diabetic Foot Ulcers With MolecuLight i:X Used in Standard of Care Compared to Standard of Care Alone
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
61
Start Date
2020-02-14
Completion Date
2024-04-01
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
ILD Research Centre
Vista, California, United States
Northwell Comprehensive Wound Healing Center and Hyperbarics
Lake Success, New York, United States
SerenaGroup Monroeville
Monroeville, Pennsylvania, United States