N/A
Completed N=30
Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds
Wounds and Injuries
Source: ClinicalTrials.gov NCT03091361 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples — 100 percentage of PPV of red fluorescence
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples |
100 | — |
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
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. Informational only — not medical advice.