Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators