Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic; Infection
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel
      cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized
      to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with
      either (A) daily application of a gentamicin-sponge, (B) daily application of a
      placebo-sponge or (C) no-sponge, in the ratio 2:1:1.

      Patients will be treated for approximately 28 days and return to the clinic weekly for safety
      and efficacy assessments. After completing treatment, patients will return to the clinic for
      scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.
    

Detailed description: 
      This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel
      cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized
      using an electronic randomization system to receive 1 of 3 study treatments; systemic
      antibiotic therapy and standard ulcer care with either (A) daily application of a
      gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio
      2:1:1. The investigator will be blinded to the patient's treatment group assignment and
      patients randomized to one of the 2 sponge groups will be blinded as to whether the sponge is
      active or placebo.

      If a patient has multiple infected ulcers, the assigned treatment will be administered to all
      infected ulcers. The investigator will determine the highest severity ulcer to be used for
      all efficacy evaluations and will also determine the size and number of sponges (up to 4)
      that a patient will use in order to completely cover all infected ulcers. The investigator
      will prescribe an empiric systemic antibiotic therapy based on protocol instructions.

      Patients will be treated for approximately 28 days and return to the clinic weekly for safety
      and efficacy assessments. The investigator will stop study treatment if a patient achieves
      clinical cure by or after the 3rd treatment visit (approximately study day 15). After
      completing treatment, patients will return to the clinic for scheduled follow-up visits or
      until ulcer closure. The final efficacy assessments used in the primary efficacy analyses
      will be obtained at the first follow-up visit approximately 10 days after treatment is
      stopped. The remaining follow-up visits will occur at approximately 30, 60 and 90 days after
      treatment is stopped when patients will be assessed for ulcer closure and any re-infection.
    

Intervention name(s): Gentamicin collagen sponge; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base); Matching collagen sponge
Other intervention name(s): Cogenzia
Intervention MeSH terms: Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment