drugset / Trial / NCT05174806
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
Phase 2
Completed
47 enrolled
Microbion Corporation
CUBRC · collabMTEC · collabNational Medical Research Council (NMRC), Singapore · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.
Timeline
- Start
- 2022-06-13
- Primary completion
- 2024-01-19
- Completion
- 2024-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pravibismane | Small molecule | 2.5 mg/ml | Topical |
Indications
No indication recorded.