Clinical trial NCT03540004: Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
Collaborators: name: SerenaGroup, Inc.
First posted: 2018-05-30
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).


Eligibility 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

Primary outcomes:
measure: Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.
timeFrame: 1 year
Secondary outcomes:
measure: Estimation of sensitivity and specificity of MolecuLight i:X alone
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: New Hope Podiatry Group
state: California
city: Pembroke Pines
country: United States
facility: Royal Research Group
state: Florida
city: Athens
country: United States
facility: Saint Mary's Center for Wound Healing
state: Georgia
city: Opelousas
country: United States
facility: The Wound Treatment Center at Opelousas General Health System
state: Louisiana
city: Cleveland
country: United States
facility: Cleveland Foot and Ankle Clinic
state: Ohio
city: Tulsa
country: United States
facility: The Heal Clinic
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Foot and Ankle Center
state: Pennsylvania
city: Erie
country: United States
facility: Saint Vincent Health Center
state: Pennsylvania
city: Ford City
country: United States
facility: The Foot and Ankle Wellness Center of Western Pennsylvania
state: Pennsylvania
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Serena Group Research Institute
state: Pennsylvania
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
city: El Campo
country: United States
facility: El Campo Memorial Hospital
state: Texas
city: Houston
country: United States
facility: Texas Gulf Coast Medical Group
state: Texas
Study officials:
affiliation: Serena Group Research Institute
name: Tomas E Serena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.