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Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds

NCT02682069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-26

Study results available
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Summary

This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound 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 will be used to guide the targeted sampling of a wound (punch biopsy method).

Conditions

  • Wounds

Interventions

DEVICE

MolecuLight i:X Imaging Device

The intended use of the device is to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device will be used as part of the current clinical wound assessment process which may include examination for characteristic signs and symptoms of infection. The device can capture and document either an image or video of the chronic wound where the presence of florescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.

Sponsors & Collaborators

  • Southwest Regional Wound Care Center

    collaborator OTHER

  • MolecuLight Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Wolcott, MD · Southwest Regional Wound Care Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-01-05
Completion
2017-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682069 on ClinicalTrials.gov