At a glance
ClinicalIndex Comparison Record- ✓Chronic wound of the lower limb (e.g., diabetic foot ulcer, venous leg ulcer, or other acceptable aetiology)
- ✓Red or cyan fluorescence signals observed within or around the wound on MolecuLight i:X images
- ✕Use of systemic (oral or intravenous) antibiotics
- ✕Treatment with an investigational drug within 1 month before study enrollment
- ✕Inability to consent to medical photography
- ✕Any contraindication to routine wound care and/or monitoring
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
In Brief
An observational study evaluating imaging, no intervention for Wounds and Injuries. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
no intervention