Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected… (NCT02664740) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
France60 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Participant pre-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)
Participant final inclusion criteria:
* The patient has a neuropathic foot wound:
* Classifie…