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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborator: Pherecydes Pharma

Criteria

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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification

Participant final 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 target wound is classified as P (1 or 2), E (1-30 cm^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification

• The patient's wound is mono-infected with Staphylococcus aureus (MRSA or MSSA)

Participant pre-exclusion criteria:

• The patient is participating in, or has participated in over the past three months, another trial

• The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, or is an adult under guardianship

• It is impossible to correctly inform the patient

• The patient refuses to sign the consent

• The patient is pregnant, parturient or breastfeeding

Participant final exclusion criteria:

• The patient is participating in, or has participated in over the past three months, another trial

• The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, or is an adult under guardianship

• It is impossible to correctly inform the patient

• The patient refuses to sign the consent

• The patient is pregnant, parturient or breastfeeding

• Patients who have received antibiotics within the 7 days preceding inclusion

• Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis*

• Patients with diabetic foot wounds associated with critical limb ischemia according to P = grade 3 in the PEDIS classification

• Patients whose wound is infected by a pathogen other than S. aureus (includes multi-infections) according to bacteriological sampling performed at the pre-inclusion visit