NCT04207099

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: MolecuLight Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Healing Diabetic Foot Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2019-12-20
• Last updated: 2021-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study