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

Sponsor
MolecuLight Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03540004
Collaborator
SerenaGroup, Inc. (Other)
367
Enrollment
14
Locations
31.3
Anticipated Duration (Months)
26.2
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: MolecuLight i:X Imaging Device

Study Design

Study Type:
Observational
Actual Enrollment :
367 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
May 23, 2018
Actual Primary Completion Date :
Apr 9, 2019
Anticipated Study Completion Date :
Dec 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity. [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

Secondary Outcome Measures

  1. Estimation of sensitivity and specificity of MolecuLight i:X alone [1.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Hope Podiatry Group Los Angeles California United States 90063
2 Royal Research Group Pembroke Pines Florida United States 33027
3 Saint Mary's Center for Wound Healing Athens Georgia United States 30306
4 The Wound Treatment Center at Opelousas General Health System Opelousas Louisiana United States 70570
5 Cleveland Foot and Ankle Clinic Cleveland Ohio United States 44103
6 The Heal Clinic Tulsa Oklahoma United States 74136
7 Foot and Ankle Center Bryn Mawr Pennsylvania United States 19010
8 Saint Vincent Health Center Erie Pennsylvania United States 16544
9 The Foot and Ankle Wellness Center of Western Pennsylvania Ford City Pennsylvania United States 16226
10 Armstrong County Memorial Hospital Kittanning Pennsylvania United States 16201
11 Serena Group Research Institute Pittsburgh Pennsylvania United States 15222
12 Martin Foot and Ankle York Pennsylvania United States 17402
13 El Campo Memorial Hospital El Campo Texas United States 77437
14 Texas Gulf Coast Medical Group Houston Texas United States 77036

Sponsors and Collaborators

  • MolecuLight Inc.
  • SerenaGroup, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MolecuLight Inc.
ClinicalTrials.gov Identifier:
NCT03540004
Other Study ID Numbers:
  • 18-001
First Posted:
May 30, 2018
Last Update Posted:
Mar 6, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Mar 6, 2020