Diabetes Clinical Trial
Official title:
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
Work Package 1: Observational cohort pilot safety study Work Package 2: Randomised, double-blind, placebo controlled pilot study Work Package 3: Observer-blind pilot RCT
Work Package 1
WP1 is a safety cohort pilot study targeting patients with DFU which are non-infected as
determined by the IDSA criteria. 20 participants will be recruited from Diabetic Foot Clinic
at the Royal Derby Hospital. Phage gel will be applied to the index ulcer after the first and
second sets of measures at baseline, weeks 1, 2 and 3. Samples will be taken at baseline and
weekly up to 4 weeks by surface swab and deep tissue sample for determination of bacterial
colonisation using both conventional and genotypic (molecular) microbiological methods, prior
to any IMP application.
Work Package 2
WP2 is a pilot double blind, placebo-controlled, randomised study targeting patients with
mild or moderate infection of DFUs and comparing systemic antibiotic therapy plus phage gel
against systemic antibiotics therapy plus placebo gel. A total of 50 participants from two
centres (foot clinics at Royal Derby Hospital and City Campus, Nottingham University
Hospitals NHS Trust) will be recruited. Phage gel or placebo will be applied to the index
ulcer after the first and second sets of measures at baseline, weeks 1, 2 and 3. Samples will
be taken at baseline and weekly up to 4 weeks by surface swab and deep tissue sample for
determination of bacterial colonisation using both conventional and genotypic (molecular)
microbiological methods
Work Package 3
WP3 is an observer-blind RCT targeting patients with mild diabetic foot infection by IDSA
criteria and comparing phage gel with systemic antibiotics. A total of 50 participants from
two centres (foot clinics at Royal Derby Hospital and City Campus, Nottingham University
Hospitals NHS Trust) will be recruited. Those with moderately severe infections will be
withheld from this work package because of the clinical and ethical issues associated with
withholding antibiotics in those with a moderately severe infection.
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