About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Topical anti-Staphylococcus bacteriophage therapy
- Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
Treatment groups
Sponsors and collaborators
Centre Hospitalier Universitaire de Nīmes
Lead sponsor
Phagenix
Collaborator