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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Diabetic FootStaphylococcal Infections
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).

Trial Locations (9)

30240

CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi, Le Grau-du-Roi

31059

CHRU de Toulouse - Hôpital de Rangueil, Toulouse

33000

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux

44093

CHU de Nantes - Hôtel Dieu, Nantes

59200

CH de Tourcoing, Tourcoing

75010

APHP - Hôpital Lariboisière, Paris

75651

APHP - Groupe Hospitalier Pitié-Salpetrière, Paris

94195

CH Intercommunal de Villeneuve-Saint-Georges, Villeneuve-Saint-Georges

94460

Institut Robert Merle d'Aubigné, Valenton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Phaxiam Therapeutics

INDUSTRY

lead

Centre Hospitalier Universitaire de Nīmes

OTHER