The use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomised Controlled Trial

Diabetic foot ulcers (DFU) have considerable morbidity and mortality, negatively impact patients’ quality of life and are of significant cost to health services.  Despite guideline recommended management less than half of DFUs in the UK have healed by 12 weeks1. Bacterial autofluorescence imaging* has been shown to improve healing of chronic wounds in case series2.  We aim to investigate the clinical effectiveness and decision making associated with the use of bacterial autofluorescence imaging in the management of DFU.

This is a single centre, pilot randomised controlled trial (RCT) in patients with a DFU, with blinded outcome assessment.  Patients were randomised in a 1:1 allocation ratio to either treatment as usual (TAU) informed by bacterial autofluorescence imaging, or TAU alone, stratified by ulcer location and vascular status. Trial visits occurred at week 0, 4, 8 and 12. The primary outcome is the proportion of ulcers healed at 12 weeks. Secondary outcomes include ulcer healing rate, patient quality of life and change in management decisions following bacterial autofluorescence imaging.

56 patients were randomised. 50 have completed follow up, 4 were lost to follow up, 1 withdrew from the trial and 1 died due to unrelated cause. 
Using a worst-case scenario ITT analysis, the proportion of ulcers healed with the use of bacterial autofluorescence imaging (n=13, 45%) at 12 weeks was significantly higher than those with TAU alone (n=5, 19%; p=0.035). Further wound debridement was the most common intervention in those with positive imaging.

To our knowledge, in the first RCT assessing the use of auto fluorescent imaging in the management of DFUs, we have shown it to be a valuable adjunct to standard care, guiding interventions with promising results in the treatment group. Further definitively powered studies can be based on these results.

Trademarked Items (if applicable): Moleculight i:X™

References (if applicable): 1. National Diabetes Foot Care Audit Report 2014-2017. https://files.digital.nhs.uk/pdf/e/9/ndfa-3ar-rep.pdf
2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, et al. (2015) Point-of-Care Autofluorescence Imaging for Real-Time Sampling and Treatment Guidance of Bioburden in Chronic Wounds: First-in-Human Results. PLoS ONE10(2): e0116623