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

• Sponsor: MolecuLight Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02682069
• Collaborator: Southwest Regional Wound Care Center (Other)
• Enrollment: 30
• Arm: 1
• Duration (Months): 18.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: MolecuLight i:X Imaging Device	N/A

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 standard practice at each local clinic. 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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X(TM) Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Jan 5, 2017
• Actual Study Completion Date: Aug 30, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: All patients There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.

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.

Outcome Measures

Primary Outcome Measures

1. Positive Predictive Value (PPV) - Ability of Fluorescence Imaging With the MolecuLight i:X to Predict Presence of Bacterial Loads of 104 CFU/g and Greater [Baseline]

   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,

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Male or female patients presenting with chronic wound of the lower limb (e.g. diabetic foot ulcer, venous leg ulcer, other acceptable aetiology)

2. 18 years or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrolment

2. Use of systemic (oral or intravenous) antibiotics

3. Inability to consent

4. Any contra-indication to routine wound care and/or monitoring

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MolecuLight Inc.
• Southwest Regional Wound Care Center

Investigators

• Principal Investigator: Ron Wolcott, MD, Southwest Regional Wound Care Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MolecuLight Inc.
• ClinicalTrials.gov Identifier: NCT02682069
• Other Study ID Numbers: 16-001
• First Posted: Feb 15, 2016
• Last Update Posted: Feb 26, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by MolecuLight Inc.: Diabetic foot ulcer; venous leg ulcer; fluorescence imaging; wound imaging
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	All Patients
Arm/Group Description	There is one arm to this study and all patients will undergo the same procedures.The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations.Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.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.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	6 20%
Male	24 80%
Region of Enrollment (Count of Participants)
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Positive Predictive Value (PPV) - Ability of Fluorescence Imaging With the MolecuLight i:X to Predict Presence of Bacterial Loads of 104 CFU/g and Greater
Description	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,
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description	There is one arm to this study and all patients will undergo the same procedures. The test of this technology is on a per wound basis where bacteria will fluoresce red and samples will be obtained from the discrete red locations. Microbiology results indicating the presence or absence of bacteria will be correlated to the fluorescence signal in the fluorescent images.
Measure Participants	30
Number [Percentage of PPV]	100

Adverse Events

Arm/Group Title	All Patients (Imaging/no Intervention)
Arm/Group Description	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.
All Cause Mortality
	All Patients (Imaging/no Intervention)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Patients (Imaging/no Intervention)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	All Patients (Imaging/no Intervention)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.