None listed
Conditions
Brief summary
AURA is a single-centre, outcome-blind pilot randomised controlled trial (RCT) designed to evaluate the effectiveness of autofluorescence-guided antimicrobial dressings in managing diabetic foot ulcers (DFUs). Conducted at Fiona Stanley Hospital (FSH), the trial will recruit adult patients from podiatry outpatient and Multidisciplinary Diabetic Foot Ulcer (MDFU) clinics. Eligible participants will be those with a DFU with <50% reduction in area in 4 weeks (“hard to heal ulcers”). Baseline data will be collected in accordance with international standards for DFU management. All participants will have their wounds cleansed and imaged using the MolecuLight i:X device to detect autofluorescence (AF), which indicates bacterial presence. Participants with negative AF (AF-) will receive standard care, including offloading, infection management, glucose control, and sharp debridement, along with inert dressings selected for exudate control, comfort, and cost. Participants with positive AF (AF+) will be randomised into two groups: one receiving antimicrobial dressings (AF+AD) and the other receiving inert dressings (AF+C), both alongside standard care. Dressing changes between clinic visits will be managed by carers or community nurses. All participants will attend follow-up appointments every two weeks over a 12-week period for ongoing podiatric treatment and wound evaluation. The study aims to recruit 60 AF+ patients, with 30 allocated to each treatment arm. The trial’s goal is to assess whether autofluorescence-guided antimicrobial dressing use improves DFU outcomes compared to inert dressings, potentially informing future clinical practice and larger-scale studies.
Interventions
The MolecuLight i:X will be used to detect harmful bacteria in wounds. It fluoresces violet light (red or cyan) in the presence of endogenously produced porphyrins from common pathogens including gram positive, gram negative, aerobic and anaerobic bacteria, as well as pyoverdine virulence factors from pseudomonas aeruginosa. It will be used to screen patients for randomisation.
Patients with positive autofluorescence will be randomised either to receive a topical antimicrobial (silver) dressin
The MolecuLight i:X will be used to detect harmful bacteria in wounds. It fluoresces violet light (red or cyan) in the presence of endogenously produced porphyrins from common pathogens including gram positive, gram negative, aerobic and anaerobic bacteria, as well as pyoverdine virulence factors from pseudomonas aeruginosa. It will be used to screen patients for randomisation. Patients with positive autofluorescence will be randomised either to receive a topical antimicrobial (silver) dressing or an inert dressing. Those with negative autofluorescence will receive an inert dressings. These autofluorescence and dressings will be applied by podiatrists in the Multidisciplinary Diabetes Foot Ulcer (MDFU) clinic or Podiatry Clinic - and it will take approximately 30-45 minutes. The patient will be expected to continue in the same arm of dressing treatment until 12 weeks following recruitment. In between appointments, dressings will be changed by patients' community nurses or their GP, as current practice. Information regarding participation in the trial will be sent to these parties. The dressing choices in both arms are representative of standard of care, and offer different levels of exudate absorption depending on how heavy the wound is exuding; there should be no practical reason for deviation from the allocated arm. Nontheless, we will ask each patient at each appointment if deviation from the allocated arm of dressings has occurred to monitor adherence, and this will be noted in REDCap. All wounds will be debrided and secondary dressings selected on the principles of exudate control, comfort and cost. This is part of current standard of care in the unit.
Sponsors
South Metropolitan Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients attending the Fiona Stanley Hospital Podiatry outpatient or Multidisciplinary Diabetes Foot Ulcer Clinics (MDFU). • Patients aged >18 years • Diabetes (Type 1 or 2) defined according to international consensus guidelines • Clinical diagnosis of DFU, defined as a full thickness epithelial defect below or distal to the ankle, present for at least 2 weeks at time of providing consent. • They should have less than 50% reduction in ulcer area 4 weeks after initial treatment, including any limb revascularisation (so-called “resistant/hard to heal DFU”). • Toe pressure >40mmHg • Competent and willing to provide informed consent • Able and willing to be followed up at 2 weekly intervals for 12 weeks and again at the 6 month mark.
Exclusion criteria
• Inability or not competent to provide informed consent • Exposed bone or previous diagnosed osteomyelitis • Peripheral artery disease (PAD) with toe pressure <40mmHg • Unlikely to be accessible for follow-up visit over 12 weeks following enrolment
Outcome results
None listed