NCT05174806

Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients

A Randomized, Open Label, Controlled, Phase 2, Multi-Center Study to Assess Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 (Pravibismane Topical Suspension) in Subjects With Moderate Diabetic Foot Infection (DFI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Microbion Corporation · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open label, controlled, multi-center study. Patients with diabetes mellitus (either type 1 or 2) and an infected wound of the foot with an International Working Group Diabetic Foot (IWGDF) severity rating of moderate will be eligible for the trial after meeting all inclusion criteria and none of the exclusion criteria. Patients (n = 54) will be randomized in a 2:1 ratio (MBN-101: standard of care). Randomization will be stratified by site. Patients randomized to the MBN-101 arm will be treated in an outpatient facility 3 times per week for the first 2 weeks. During each of the subsequent 10 weeks, patients will be treated once per week at the outpatient clinic and will be provided with enough MBN-101 for 2 additional days of treatment for self administration at home with or without the assistance of a caregiver. The duration between each dose should be greater than 24 hours, yet not exceed 72 hours for each of the 12 treatment weeks. Patients randomized to the standard of care arm will follow the same schedule (i.e., inclusive of wound dressing changes), though will not be treated with MBN-101. All subjects will initially receive systemic antibiotic treatment and undergo appropriate sharp debridement at baseline and then as directed by the treating physician through the 12-week treatment period, yet part of the standard of care treatment.

Conditions

• Diabetic Foot Infection
• Diabetic Foot

Interventions

Type	Name	Description
DRUG	Topical Pravibismane	Topical Pravibismane
OTHER	Standard of Care	Standard of care treatment without investigational topical pravibismane (MBN-101) or other topical antibiotics.

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2022-01-03
• Last updated: 2024-11-04

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study