RESEARCH ARTICLE Point-of-Care Autofluorescence Imaging for Real-Time Sampling and Treatment Guidance of Bioburden in Chronic Wounds: First-in-Human Results

Background Traditionally, chronic wound infection is diagnosed by visual inspection under white light and microbiological sampling, which are subjective and suboptimal, respectively, thereby delaying diagnosis and treatment. To address this, we developed a novel handheld, fluores-cence imaging device (PRODIGI) that enables non-contact, real-time, high-resolution visu-alization and differentiation of key pathogenic bacteria through their endogenous autofluorescence, as well as connective tissues in wounds. Methods and Findings This was a two-part Phase I, single center, non-randomized trial of chronic wound patients (male and female,18 years; UHN REB #09-0015-A for part 1; UHN REB #12-5003 for part 2; clinicaltrials.gov Identifier: NCT01378728 for part 1 and NCT01651845 for part 2). Part 1 (28 patients; 54 % diabetic foot ulcers, 46 % non-diabetic wounds) established the fea-sibility of autofluorescence imaging to accurately guide wound sampling, validated against blinded, gold standard swab-based microbiology. Part 2 (12 patients; 83.3 % diabetic foot ul