Overview

Multi-center Study to Assess Safety, Tolerability and Efficacy of MBN-101 in Patients With Moderate/Severe DFI

Status:
Not yet recruiting

Trial end date:
2023-07-01

Target enrollment:

Participant gender:

Summary

This is a randomized, open label, controlled study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied MBN-101 in hospitalized patients with diabetic foot infection. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical MBN-101 will be applied once daily for the first week of treatment and three times per week for up to 11 additional weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

Phase:

Phase 2

Details

Lead Sponsor:

Microbion Corporation

Collaborator:

CUBRC, MTEC, and US Navy