N/A N=30

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

Wounds and Injuries

Bottom Line

View on ClinicalTrials.gov: NCT03091361 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples — 100 percentage of PPV of red fluorescence

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: imaging, no intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MolecuLight Inc.
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples	100	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03091361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.