The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.
The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient has type 1 or type 2 diabetes
The patient is participating in, or has participated in over the past three months, another trial
The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study
The patient is in an exclusion period determined by a previous study
The patient is under judicial protection, or is an adult under guardianship
Parallel
Topical anti-Staphylococcus bacteriophage therapy
DrugPatients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10\^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).
Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
DrugPatients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).
The relative reduction in wound surface area (%)
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
The number of MedDRA coded Adverse Events per patient
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Centre Hospitalier Universitaire de Nīmes
Lead sponsor
Phagenix
Collaborator
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