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NOT YET RECRUITING
NCT02664740
PHASE1/PHASE2

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

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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