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

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: Wound
• Intervention / Treatment: Device: MolecuLight i:X Imaging Device

• Study Type: Observational
• Enrollment (Actual): 367

Contacts and Locations

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

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

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.	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	1.5 years

Collaborators and Investigators

• Sponsor: MolecuLight Inc.
• Collaborators: SerenaGroup, Inc.
• Investigators: Principal Investigator: Tomas E Serena, MD, Serena Group Research Institute

Publications and helpful links

General Publications

• Serena TE, Gould L, Ousey K, Kirsner RS. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: Post hoc Analysis of 350 Chronic Wounds. Adv Wound Care (New Rochelle). 2022 Dec;11(12):639-649. doi: 10.1089/wound.2021.0146. Epub 2021 Dec 3.

Study record dates

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: Wounds and Injuries
• 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