N/A
Completed N=30
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
Source: ClinicalTrials.gov NCT02682069 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: 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 — 100 Percentage of PPV
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
100 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients presenting with chronic wound of the lower limb (e.g. diabetic foot ulcer, venous leg ulcer, other acceptable aetiology)
- 18 years or older
Exclusion Criteria
- Treatment with an investigational drug within 1 month before study enrolment
- Use of systemic (oral or intravenous) antibiotics
- Inability to consent
- Any contra-indication to routine wound care and/or monitoring
Data sourced from ClinicalTrials.gov (NCT02682069). 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.