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Not listed No phase listed Observational

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

ClinicalTrials.gov ID: NCT03540004

Public ClinicalTrials.gov record NCT03540004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03540004
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
MolecuLight Inc.
Industry
Enrollment
367 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 22, 2018
Primary completion
Apr 8, 2019
Completion
Dec 29, 2020
Last update posted
Mar 5, 2020

2018 – 2020

United States locations

U.S. sites
14
U.S. states
8
U.S. cities
14
Facility City State ZIP Site status
New Hope Podiatry Group Los Angeles California 90063
Royal Research Group Pembroke Pines Florida 33027
Saint Mary's Center for Wound Healing Athens Georgia 30306
The Wound Treatment Center at Opelousas General Health System Opelousas Louisiana 70570
Cleveland Foot and Ankle Clinic Cleveland Ohio 44103
The Heal Clinic Tulsa Oklahoma 74136
Foot and Ankle Center Bryn Mawr Pennsylvania 19010
Saint Vincent Health Center Erie Pennsylvania 16544
The Foot and Ankle Wellness Center of Western Pennsylvania Ford City Pennsylvania 16226
Armstrong County Memorial Hospital Kittanning Pennsylvania 16201
Serena Group Research Institute Pittsburgh Pennsylvania 15222
Martin Foot and Ankle York Pennsylvania 17402
El Campo Memorial Hospital El Campo Texas 77437
Texas Gulf Coast Medical Group Houston Texas 77036

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03540004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 5, 2020 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03540004 live on ClinicalTrials.gov.

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