drugset / Trial / NCT01951768
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
Timeline
- Start
- 2013-09
- Primary completion
- 2016-06
- Completion
- 2016-06
Publications
- Background Uckay I, Kressmann B, Malacarne S, Toumanova A, Jaafar J, Lew D, Lipsky BA. A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection. BMC Infect Dis. 2018 Aug 2;18(1):361. doi: 10.1186/s12879-018-3253-z.
- Background Uckay I, Kressmann B, Di Tommaso S, Portela M, Alwan H, Vuagnat H, Maitre S, Paoli C, Lipsky BA. A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE Open Med. 2018 May 13;6:2050312118773950. doi: 10.1177/2050312118773950. eCollection 2018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gentamicin | Small molecule | 50 mg | Topical |
| Comparator | Amoxicillin/clavulanate | Unknown | 125 mg | — |
| Comparator | Amoxicillin/clavulanate | Unknown | 200 mg | — |
| Comparator | Amoxicillin/clavulanate | Unknown | 500 mg | — |
| Comparator | Amoxicillin/clavulanate | Unknown | 1000 mg | — |
| Comparator | Aztreonam | Small molecule | 1 g | — |
| Comparator | Aztreonam | Small molecule | 2 g | — |
| Comparator | Clindamycin | Unknown | 300 mg | — |
| Comparator | Clindamycin | Unknown | 450 mg | — |
| Comparator | Clindamycin | Unknown | 600 mg | — |
| Comparator | Levofloxacin | Small molecule | 500 mg | — |
| Comparator | Levofloxacin | Small molecule | 750 mg | — |
| Comparator | Linezolid | Other / unclassified | 600 mg | — |
| Comparator | Metronidazole | Small molecule | 400 mg | — |
| Comparator | Metronidazole | Small molecule | 500 mg | — |
| Comparator | Piperacillin/tazobactam | Unknown | 375 mg | — |
| Comparator | Piperacillin/tazobactam | Unknown | 500 mg | — |
| Comparator | Piperacillin/tazobactam | Unknown | 3000 mg | — |
| Comparator | Piperacillin/tazobactam | Unknown | 4000 mg | — |