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NCT05174806

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

Completed Phase 2 Last updated 4 November 2024
What this trial tests

Phase 2 trial testing Topical Pravibismane in Diabetic Foot Infection in 47 participants. Completed in 19 January 2024.

Timeline
13 June 2022
Primary endpoint
19 January 2024
19 January 2024

Quick facts

Lead sponsorMicrobion Corporation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment47
Start date13 June 2022
Primary completion19 January 2024
Estimated completion19 January 2024
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Microbion Corporation — full company profile →

Who can join

Adults 18 to 79, any sex, with Diabetic Foot Infection or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibiotics in the clinical pipeline as of December 2022.
    Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
  2. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
    Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x
  3. Staph wars: the antibiotic pipeline strikes back.
    Douglas EJA, Laabei M. · · 2023 · cited 10× · PMID 37656158 · DOI 10.1099/mic.0.001387
  4. Diabetes and its complications: molecular mechanisms, prevention and treatment.
    Zhao L, Yuan J, Yang Q, Ma J, et al · · 2026 · cited 2× · PMID 41549124 · DOI 10.1038/s41392-025-02401-w

Verify or expand the search:

Other recruiting trials for Diabetic Foot Infection

Currently open trials in the same condition.

Other Microbion Corporation trials

Trials by the same sponsor.

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Data sources for this page

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