An interventional study of Moleculight i:X™ fluorescence imaging in Ulcer Foot, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15.
A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection.
This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.
Exclusion Criteria:
Participants in this group have been randomised to receive application of violet blue light administered by the hand held Microlight i:X device in addition to routine care of their foot ulcer. This intervention will be administered four times during the study.
Device: Moleculight i:X™ fluorescence imaging
This group receive routine care and no additional intervention.
Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
The proportion of diabetic foot ulcers healed at 12 weeks post randomisation
The proportion of diabetic foot ulcers which have healed in both group 1 and group 2 at 12 weeks.
Time frame: 12 weeks
Plan to share: No
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The Leeds Teaching Hospitals NHS Trust