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

Inclusion Criteria

• •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 hospitalized/consulting in a participating centre
• •The patient has a wound below the ankle that has be evolving for \>2 weeks
• •The patient has a neuropathic foot wound, classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,
• •* without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \> 50 mm Hg or toe systolic arterial pressure \> 30 mm Hg or TcpO2 \> 30 mm Hg )
• •* with a surface area ≥ 0,5 cm2
• •* With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis (normal radiography\*)
• •Females of childbearing potential or Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration
• •Negative pregnancy test must be obtained before starting any experimental drug
• •Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
• •The patient has a neuropathic foot wound:
• •* Classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,
• •without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \> 50 mm Hg or toe systolic arterial pressure \> 30 mm Hg or TcpO2 \> 30 mm Hg )
• •with a surface area ≥ 0,5 cm2
• •* With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis
• •The patient's wound is monoinfected by methicillin-resistant or susceptible S. aureus (MSSA or MRSA ), or infected by MSSA or MRSA and other bacteria (a total of 3 bacteria when accounting for MSSA or MRSA)
• •The Phagogram of the patient demonstrated that the strains are susceptible to at least one phage(PP1493 and/or PP1815).