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

Status:	Recruiting
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/8/2019
Start Date:	May 23, 2018
End Date:	December 30, 2019
Contact:	Sharon McConnell, MS
Email:	smcconnell@serenagroups.com
Phone:	8147063318

A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Saint Vincent Health Center

Erie, Pennsylvania 16544

Principal Investigator: Daniel DiMarco, DO

from

Erie, PA