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

March 4, 2020 updated by: MolecuLight Inc.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90063
        • New Hope Podiatry Group
    • Florida
      • Pembroke Pines, Florida, United States, 33027
        • Royal Research Group
    • Georgia
      • Athens, Georgia, United States, 30306
        • Saint Mary's Center for Wound Healing
    • Louisiana
      • Opelousas, Louisiana, United States, 70570
        • The Wound Treatment Center at Opelousas General Health System
    • Ohio
      • Cleveland, Ohio, United States, 44103
        • Cleveland Foot and Ankle Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • The Heal Clinic
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Foot and Ankle Center
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Health Center
      • Ford City, Pennsylvania, United States, 16226
        • The Foot and Ankle Wellness Center of Western Pennsylvania
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong County Memorial Hospital
      • Pittsburgh, Pennsylvania, United States, 15222
        • Serena Group Research Institute
      • York, Pennsylvania, United States, 17402
        • Martin Foot and Ankle
    • Texas
      • El Campo, Texas, United States, 77437
        • El Campo Memorial Hospital
      • Houston, Texas, United States, 77036
        • Texas Gulf Coast Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimation of sensitivity and specificity of MolecuLight i:X alone
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MolecuLight Inc.

Collaborators

SerenaGroup, Inc.

Investigators

  • Principal Investigator: Tomas E Serena, MD, Serena Group Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2018

Primary Completion (Actual)

April 9, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 4, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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