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

NCT02664740 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Diabetic Foot
  • Staphylococcal 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).

Sponsors & Collaborators

  • Phaxiam Therapeutics

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Albert Sotto, MD, PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664740 on ClinicalTrials.gov