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Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
Sponsor: Centre Hospitalier Universitaire de Nīmes
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.
Official title: Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-09-01
Completion Date
2028-11
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Topical anti-Staphylococcus bacteriophage therapy
Patients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10\^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).
Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
Patients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).
Locations (6)
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, France
Hopital européen
Marseille, France
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, France
CH de Tourcoing
Tourcoing, France
CH Intercommunal de Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, France