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

Wound Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03540004
• Other study ID #: 18-001
• Status: Active, not recruiting
• Start date: May 23, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: MolecuLight Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 367
• Est. completion date: December 30, 2020
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Signs and Symptoms
• Wound
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Mary's Center for Wound Healing	Athens	Georgia
United States	Foot and Ankle Center	Bryn Mawr	Pennsylvania
United States	Cleveland Foot and Ankle Clinic	Cleveland	Ohio
United States	El Campo Memorial Hospital	El Campo	Texas
United States	Saint Vincent Health Center	Erie	Pennsylvania
United States	The Foot and Ankle Wellness Center of Western Pennsylvania	Ford City	Pennsylvania
United States	Texas Gulf Coast Medical Group	Houston	Texas
United States	Armstrong County Memorial Hospital	Kittanning	Pennsylvania
United States	New Hope Podiatry Group	Los Angeles	California
United States	The Wound Treatment Center at Opelousas General Health System	Opelousas	Louisiana
United States	Royal Research Group	Pembroke Pines	Florida
United States	Serena Group Research Institute	Pittsburgh	Pennsylvania
United States	The Heal Clinic	Tulsa	Oklahoma
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MolecuLight Inc.	SerenaGroup, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimation of sensitivity and specificity of MolecuLight i:X alone		1.5 years