Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds

A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Bacteria in Chronic Wounds

This is a non-randomized, single-blind post market clinical follow-up study for which 50 patients will be imaged at the Judy Dan Research and Treatment Centre who present with a chronic and are receiving standard wound care treatment. The i:X imaging device visualizes fluorescing bacteria in real-time. The 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 (with curettage scraping). The overall objective of this work is to evaluate the positive predictive value (PPV) of the MolecuLight i:X Imaging Device in predicting the presence of bacteria in chronic wounds. The presence of bacteria will be determined micro-biologically by semi-quantitative culture analysis.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Other: imaging, no intervention

Detailed Description

MolecuLight Inc. (Toronto, Canada) has recently introduced to the Canadian market an innovative imaging device, the MolecuLight i:X™ Imaging Device, that offers real-time detection of important biological and molecular information of a chronic wound, and could have significant impact on improving conventional wound care and management. The MolecuLight i:X Imaging Device is intended to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device can capture and document either an image or video of the chronic wound where the presence of fluorescent 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. Though the MolecuLight i:X Imaging Device has been shown to be effective in controlled settings, this study is deploying the device in a larger population and evaluating the ability of the MolecuLight i:X device to positively predict the presence of bacteria in chronic wounds.

The overall objective of this work is to evaluate the MolecuLight i:X Imaging Device in screening of chronic wounds for the presence of bacteria. The device is intended to guide the clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.

All imaging will be performed with the MolecuLight i:X Imaging Device at an appropriate distance from the wound of interest (8 - 12 cm), which is indicated by the range finder LED. Illumination is provided by two violet (405 nm) LEDs that produce a bright, but clinically safe, uniform illumination. Fluorescence imaging is performed on the camera in real-time while the device is in fluorescence mode and the room lights are turned off. If room ambient light cannot be eliminated to an acceptable level (indicated by the ambient light sensor), the MolecuLight drape must be used to achieve a dark environment. A standard measurement sticker will be placed adjacent to the wound within the field of view to act as a reference for size.

All microbiological analysis will be performed as per clinic standard practice. Tissue samples will be analyzed for culture and sensitivity, yielding the species of bacteria present in the sample (if any), the susceptibility to various antibiotics and a measure of the bacterial load.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M2R 1N5
      • Judy Dan Research and Treatment Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving routine wound care.

Description

Inclusion Criteria:

• presents with a chronic wound of the lower limb (e.g. diabetic foot ulcer, venous leg ulcer, other acceptable aetiology)
• red or cyan fluorescence signals observed within or around wound on MolecuLight i:X images

Exclusion Criteria:

• Treatment with an investigational drug within 1 month before study enrollment
• Use of systemic (oral or intravenous) antibiotics
• Inability to consent to medical photography
• Any contra-indication to routine wound care and/or monitoring

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All patients (imaging/no intervention); There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.

Other: imaging, no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples	PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,	3 months

Collaborators and Investigators

• Sponsor: MolecuLight Inc.
• Investigators: Principal Investigator: Ron Linden, MD, Judy Dan Research and Treatment Center

Publications and helpful links

General Publications

• Rennie MY, Lindvere-Teene L, Tapang K, Linden R. Point-of-care fluorescence imaging predicts the presence of pathogenic bacteria in wounds: a clinical study. J Wound Care. 2017 Aug 2;26(8):452-460. doi: 10.12968/jowc.2017.26.8.452.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Chronic wounds; PPV; Bacterial imaging
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 16-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO