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

Study acronym: PhagoPied
StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Aug 2024 to Nov 2028 Start date: Jun 1, 2022 to Sep 1, 2026 · Study sites: 9 to 6 · Eligibility criteria expanded, about 136 wordsv9 Show 3 more changesShow less
    • Start date: Jun 1, 2022 to Sep 1, 2026
    • Study sites: 9 to 6
    • Eligibility criteria expanded, about 136 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jan 1, 2022 to Jun 1, 2022v8
  3. Primary and study completion dates: Aug 2023 to Aug 2024 Start date: Jan 1, 2021 to Jan 1, 2022v7 Show 1 more changeShow less
    • Start date: Jan 1, 2021 to Jan 1, 2022
  4. Primary and study completion dates: Aug 2022 to Aug 2023 Start date: Jun 2020 to Jan 1, 2021v6 Show 1 more changeShow less
    • Start date: Jun 2020 to Jan 1, 2021
  5. Primary and study completion dates: Aug 2019 to Aug 2022 Start date: Jan 2019 to Jun 2020v5 Show 1 more changeShow less
    • Start date: Jan 2019 to Jun 2020
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jan 2018 to Jan 2019v4
  2. Primary and study completion dates: Aug 2018 to Aug 2019 Start date: Jan 2017 to Jan 2018v3 Show 1 more changeShow less
    • Start date: Jan 2017 to Jan 2018
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02664740
Lead Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators: Phagenix
Conditions Diabetic Foot, Staphylococcal Infections
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov