Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds

UnknownOBSERVATIONAL
Enrollment

367

Participants

Timeline

Start Date

May 23, 2018

Primary Completion Date

April 9, 2019

Study Completion Date

December 30, 2020

Conditions
Wound
Interventions
DEVICE

MolecuLight i:X Imaging Device

The 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 (14)

15222

Serena Group Research Institute, Pittsburgh

16201

Armstrong County Memorial Hospital, Kittanning

16226

The Foot and Ankle Wellness Center of Western Pennsylvania, Ford City

16544

Saint Vincent Health Center, Erie

17402

Martin Foot and Ankle, York

19010

Foot and Ankle Center, Bryn Mawr

30306

Saint Mary's Center for Wound Healing, Athens

33027

Royal Research Group, Pembroke Pines

44103

Cleveland Foot and Ankle Clinic, Cleveland

70570

The Wound Treatment Center at Opelousas General Health System, Opelousas

74136

The Heal Clinic, Tulsa

77036

Texas Gulf Coast Medical Group, Houston

77437

El Campo Memorial Hospital, El Campo

90063

New Hope Podiatry Group, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

MolecuLight Inc.

INDUSTRY

NCT03540004 - Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds | Biotech Hunter | Biotech Hunter