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

Status unconfirmed

Conditions studied: Wound

In brief

This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).

Key facts

Study ID

NCT03540004

Run by

MolecuLight Inc.

People needed

367

Starts

2018-05-23

Expected to finish

2020-12-30

Last updated by the study team

2020-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
• 18 years or older

You may not qualify if…

• Treatment with an investigational drug within 1 month before study enrolment
• Subjects with recent (<30 days) biopsy of target wound
• Subjects with wounds that cannot be completely imaged by study device due to anatomic location
• Inability to consent
• Any contra-indication to routine wound care and/or monitoring

Where it is running

• New Hope Podiatry Group — Los Angeles, California, United States
• Royal Research Group — Pembroke Pines, Florida, United States
• Saint Mary's Center for Wound Healing — Athens, Georgia, United States
• The Wound Treatment Center at Opelousas General Health System — Opelousas, Louisiana, United States
• Cleveland Foot and Ankle Clinic — Cleveland, Ohio, United States
• The Heal Clinic — Tulsa, Oklahoma, United States
• Foot and Ankle Center — Bryn Mawr, Pennsylvania, United States
• Saint Vincent Health Center — Erie, Pennsylvania, United States
• The Foot and Ankle Wellness Center of Western Pennsylvania — Ford City, Pennsylvania, United States
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States
• Serena Group Research Institute — Pittsburgh, Pennsylvania, United States
• Martin Foot and Ankle — York, Pennsylvania, United States
• El Campo Memorial Hospital — El Campo, Texas, United States
• Texas Gulf Coast Medical Group — Houston, Texas, United States

Full record on ClinicalTrials.gov

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