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

NCT05174806 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-11-04

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Infection
  • Diabetic Foot

Interventions

DRUG

Topical Pravibismane

Topical Pravibismane

OTHER

Standard of Care

Standard of care treatment without investigational topical pravibismane (MBN-101) or other topical antibiotics.

Sponsors & Collaborators

  • CUBRC

    collaborator UNKNOWN

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • MTEC

    collaborator UNKNOWN

  • Microbion Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2024-01-19
Completion
2024-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05174806 on ClinicalTrials.gov