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

NCT05174806 | Completed Phase 2 FDA Drug

• 1 other identifier: MBN-101-203
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Amputation; DFI; Wound closure; Diabetic Foot Infection; Pravibismane; Clinical Cure; Safety and tolerability

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with adverse events

  Safety and tolerability

  12 weeks

Secondary Outcomes (3)

• Proportion of subjects with complete wound closure

  12 weeks

• Proportion of subjects with a clinical cure of infection

  12 weeks

• Proportion of subjects undergoing lower-extremity amputation

  12 weeks

Study Arms (2)

Topical Pravibismane (MBN-101)

EXPERIMENTAL

Topical pravibismane (MBN-101) at a dose of 2.5 mg/mL will be applied directly to the infected wound and covered with an appropriate non-antimicrobial dressing. Dosing will occur 3 times per week for the 12 weeks of treatment.

Drug: Topical Pravibismane

Standard of Care

OTHER

Standard of care treatment without administration of any topical drugs.

Other: Standard of Care

Interventions

Topical Pravibismane DRUG

Topical Pravibismane

Also known as: MBN-101

Topical Pravibismane (MBN-101)

Standard of Care OTHER

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

Also known as: SOC comparator

Standard of Care

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
• Has a skin ulcer located on or distal to the malleolus that is ≥ 4 weeks that is clinically documented, and presents with clinical manifestations of a moderate infection (i.e. erythema extending ≥ 2.0 cm from the wound margin), and not requiring hospitalization.
• Has received no more than 36 hours of antibiotic therapy for the moderately infected ulcer prior to enrollment or there is clinical and/or microbiological evidence of failure of antibiotic treatment for the treatment of the moderately infected ulcer.
• Has documented adequate arterial perfusion in the affected limb by biphasic or triphasic Doppler wave forms, a toe brachial index (TBI) ≥0.75, or an ankle brachial index (ABI) of \>0.9).
• Has read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained.

You may not qualify if:

• Has proven or highly suspected, involvement of bone (i.e., osteomyelitis).
• Has an ulcer due to Charcot arthropathy.
• Has more than one concurrent, infected, diabetic foot wound on the study limb.
• Is unwilling or unable to attend clinic visits and keep research appointments.
• Is unwilling or unable to adhere to the systemic antibiotic treatment prescribed.
• Is unwilling or unable to adhere to proper pressure off-loading of the foot wound (when needed) from enrollment through EOS as directed by the treating physician.
• Has an untreated, uncontrolled, or poorly managed immunosuppressive and or autoimmune disorder.
• Plans to use any topical antibiotics, herbals remedies (e.g., honey), alternative medicines or antimicrobials, either directly or by dressings on their infected DFU at any time from enrollment through the EOS visit.
• Plans to receive treatment with larvae (maggots) for their infected DFU at any time from enrollment through the EOS visit.
• Plans to receive treatment with advanced cellular therapies (e.g., Platelet-derived growth factor (PDGF), Cellular Tissue Products (CTP), granulocyte colony-stimulating factor (G CSF)) for their infected DFU at any time from enrollment through the EOS visit.
• History of major medical noncompliance.
• Any condition that has required treatment with any other bismuth containing compound within 2 weeks prior to enrollment through EOS visit (i.e., Kaopectate or Pepto-Bismol, including topical applications such as Xeroform).
• Plans to receive treatment with Hyperbaric oxygen therapy (HBOT) or topical negative pressure wound therapy (NPWT) for their infected DFU at any time from enrollment through the EOS visit.
• Glycated hemoglobin \>12%.
• Has a serum creatinine, ALT, AST or Alkaline Phosphatase \>3 times the upper limit of the normal range of the local testing laboratory.

Sponsors & Collaborators

• Microbion Corporation: lead
• CUBRC: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator
• MTEC: collaborator

Study Sites (7)

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

Location

Parkland Comprehensive Wound Center

Dallas, Texas, 75235, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center University Wound Care Clinic

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center William P. Clements Jr. University Hospital

Dallas, Texas, 75390, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Bio-X-Cell Research

San Antonio, Texas, 78224, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Topical Pravibismane (MBN-101) versus Standard of Care (SOC); 2:1 ratio.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: June 13, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)