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

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ClinicalTrials.gov Identifier: NCT03540004
Recruitment Status : Active, not recruiting
First Posted : May 30, 2018
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
SerenaGroup, Inc.
Information provided by (Responsible Party):
MolecuLight Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment
Wound Device: MolecuLight i:X Imaging Device

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Study Type : Observational
Actual Enrollment : 367 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : April 9, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity. [ Time Frame: 1 year ]

    Superiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load

    Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load



Secondary Outcome Measures :
  1. Estimation of sensitivity and specificity of MolecuLight i:X alone [ Time Frame: 1.5 years ]

Biospecimen Retention:   Samples With DNA
Soft tissue core biopsies will be obtained from patients with wounds.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540004


Locations
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United States, California
New Hope Podiatry Group
Los Angeles, California, United States, 90063
United States, Florida
Royal Research Group
Pembroke Pines, Florida, United States, 33027
United States, Georgia
Saint Mary's Center for Wound Healing
Athens, Georgia, United States, 30306
United States, Louisiana
The Wound Treatment Center at Opelousas General Health System
Opelousas, Louisiana, United States, 70570
United States, Ohio
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, United States, 44103
United States, Oklahoma
The Heal Clinic
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Foot and Ankle Center
Bryn Mawr, Pennsylvania, United States, 19010
Saint Vincent Health Center
Erie, Pennsylvania, United States, 16544
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, United States, 16226
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Martin Foot and Ankle
York, Pennsylvania, United States, 17402
United States, Texas
El Campo Memorial Hospital
El Campo, Texas, United States, 77437
Texas Gulf Coast Medical Group
Houston, Texas, United States, 77036
Sponsors and Collaborators
MolecuLight Inc.
SerenaGroup, Inc.
Investigators
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Principal Investigator: Tomas E Serena, MD Serena Group Research Institute
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Responsible Party: MolecuLight Inc.
ClinicalTrials.gov Identifier: NCT03540004    
Other Study ID Numbers: 18-001
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries