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

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Trial Summary
Trial Overview
Inclusion Criteria

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
14
sites
Armstrong County Memorial Hospital
Kittanning, Pennsylvania 16201
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Kittanning, PA
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Saint Mary's Center for Wound Healing
Athens, Georgia 30306
Principal Investigator: Rachel Hamil, MD
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from
Athens, GA
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Foot and Ankle Center
Bryn Mawr, Pennsylvania 19010
Principal Investigator: Marc Baer, DPM
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from
Bryn Mawr, PA
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Cleveland Foot and Ankle Clinic
Cleveland, Ohio 44103
Principal Investigator: Windy Cole, DPM
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from
Cleveland, OH
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El Campo Memorial Hospital
El Campo, Texas 77437
Principal Investigator: Elizabeth F Clapp, APRN
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from
El Campo, TX
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Saint Vincent Health Center
Erie, Pennsylvania 16544
Principal Investigator: Daniel DiMarco, DO
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from
Erie, PA
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The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania 16226
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from
Ford City, PA
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Texas Gulf Coast Medical Group
Houston, Texas 77036
Principal Investigator: Patrick K Briggs, DPM
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from
Houston, TX
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New Hope Podiatry Group, Inc.
Los Angeles, California 90063
Principal Investigator: Gabriel Halperin, DPM
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from
Los Angeles, CA
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The Wound Treatment Center at Opelousas General Health System
Opelousas, Louisiana 70570
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mi
from
Opelousas, LA
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Royal Research Group
Pembroke Pines, Florida 33027
Principal Investigator: Neal M Bullock, DPM
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from
Pembroke Pines, FL
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Serena Group Research Institute
Pittsburgh, Pennsylvania 15222
Phone: 412-212-0123
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from
Pittsburgh, PA
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The Heal Clinic
Tulsa, Oklahoma 74136
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from
Tulsa, OK
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Martin Foot and Ankle
York, Pennsylvania 17403
Principal Investigator: Maria Kasper, DPM
Phone: 814-706-3318
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from
York, PA
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