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

NCT03540004 | Unknown FDA Device

• 1 other identifier: 18-001
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 14

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).

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Estimation of sensitivity and specificity of MolecuLight i:X alone

  1.5 years

Interventions

MolecuLight i:X Imaging Device 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI)
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• MolecuLight Inc.: lead
• SerenaGroup, Inc.: collaborator

Study Sites (14)

New Hope Podiatry Group

Los Angeles, California, 90063, United States

Location

Royal Research Group

Pembroke Pines, Florida, 33027, United States

Location

Saint Mary's Center for Wound Healing

Athens, Georgia, 30306, United States

Location

The Wound Treatment Center at Opelousas General Health System

Opelousas, Louisiana, 70570, United States

Location

Cleveland Foot and Ankle Clinic

Cleveland, Ohio, 44103, United States

Location

The Heal Clinic

Tulsa, Oklahoma, 74136, United States

Location

Foot and Ankle Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Saint Vincent Health Center

Erie, Pennsylvania, 16544, United States

Location

The Foot and Ankle Wellness Center of Western Pennsylvania

Ford City, Pennsylvania, 16226, United States

Location

Armstrong County Memorial Hospital

Kittanning, Pennsylvania, 16201, United States

Location

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

El Campo Memorial Hospital

El Campo, Texas, 77437, United States

Location

Texas Gulf Coast Medical Group

Houston, Texas, 77036, United States

Location

Related Publications (2)

• Johnson J, Johnson AR Jr, Andersen CA, Kelso MR, Oropallo AR, Serena TE. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations. J Racial Ethn Health Disparities. 2024 Apr;11(2):1045-1055. doi: 10.1007/s40615-023-01584-8. Epub 2023 Apr 11.

  PMID: 37039975 DERIVED

• 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.

  PMID: 34714159 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Soft tissue core biopsies will be obtained from patients with wounds.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Tomas E Serena, MD

  Serena Group Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 30, 2018
• Study Start: May 23, 2018
• Primary Completion: April 9, 2019
• Study Completion: December 30, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)