Clinical trial NCT02682069: Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: Diabetic foot ulcer
venous leg ulcer
fluorescence imaging
wound imaging
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
Collaborators: name: Southwest Regional Wound Care Center
First posted: 2016-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Ron Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.