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A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer

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Trial Profile

A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2021

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At a glance

  • Drugs Gentamicin (Primary) ; Levofloxacin
  • Indications Bacterial infections; Diabetic foot ulcer; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms COACT-1
  • Sponsors Innocoll

    • Most Recent Events

    • 02 Aug 2021 Status changed from active, no longer recruiting to completed.
    • 03 Nov 2016 Results published in Innocoll Holdings plc media release.
    • 03 Nov 2016 Primary endpoint has not been met. (Clinical Cure (Resolution of all clinical signs and symptoms of infection)), as per Innocoll Holdings plc media release.
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