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
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 03 Nov 2016
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
- 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.
- 07 Jun 2016 Planned End Date changed from 1 May 2016 to 1 Aug 2016.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History