12-week RCT Evaluating Impact of Routine Fluorescence Imaging of Bacteria on Diabetic foot ulcer healing rates

Introduction:  Bacterial burden >104 CFU/g is known to delay healing1,2 and is challenging to detect in diabetic foot ulcers where co-morbidiites including neuropathy can mask clinical signs and symptoms.  Fluorescence imaging with a point-of-care device has been shown ot detect wounds with bacteria at loads >104 CFU/g3,4 with high sensitivity.  This 12 week randomized controlled trial registered with ClinicalTrials.gov NCT04207099 evaluated the effect of routine imaging on diabetic foot ulcer healing rates compared to the standard of care (SOC).Methods:  Patients with non-healing diabetic foot ulcers at two US sites were randomized to receive either SOC or SOC + fluorescence imaging for detection of elevated bacterial loads every two weeks.  Fluorescence imaging informed interventions including debridement were used to decrease bacterial fluorescence signal.  The primary outcome was wound area reduction at 12 weeks.  This interim analysis of 9 patients (4 SOC, 5 fluorescence informed) was performed to assess for futility amid COVID-19 related recruitment challenges.Results:  Seven out of nine patients had neuropathy.  All wounds were Conclusion:  These interim results suggest strong benefit of routine fluorescence imaging of bacterial loads.  The treatment decisions that were informed by imaging information appear to have accelerated diabetic foot ulcer healing rates.