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About
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.
Full description
The secondary objectives of this study are:
A. To compare the two study arms in terms of treatment safety and tolerance throughout the study.
B. To compare the two study arms in terms of further changes in wound healing at weeks 2, 4, 6, 8, 10, 12.
C. To describe the changes in the resistance and virulence of S. aureus (if present in the wound) from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
D. To describe in the two study arms the antibiotic resistance status of other bacteria isolated from wounds at week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
E. To describe in the two study arms changes in wound microbiota from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
F. To describe the production of anti-phage antibodies during the topical treatment: baseline and week 4, at modification of the first-line treatment or new antibiotic prescription (if any), and at week 12.
G. Creation of a biobank for future ancillary studies (including, but not limited to, cytokine levels and cellular immune responses): days 0 and week 4, as well as week 12.
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Participant pre-inclusion criteria:
Participant final inclusion criteria:
Participant pre-exclusion criteria:
Participant final exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
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Central trial contact
Albert Sotto, MD, PhD; Carey Suehs, PhD
Data sourced from clinicaltrials.gov
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