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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Topical Pravibismane
Standard of care treatment without investigational topical pravibismane (MBN-101) or other topical antibiotics.
Limb Preservation Platform, Inc.
Fresno, California, United States
Parkland Comprehensive Wound Center
Dallas, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center University Wound Care Clinic
Dallas, Texas, United States
University of Texas Southwestern Medical Center William P. Clements Jr. University Hospital
Dallas, Texas, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Bio-X-Cell Research
San Antonio, Texas, United States
Proportion of patients with adverse events
Safety and tolerability
Time frame: 12 weeks
Proportion of subjects with complete wound closure
Effect of MBN-101 suspension on wound healing
Time frame: 12 weeks
Proportion of subjects with a clinical cure of infection
Effect of MBN-101 suspension on resolution of infection
Time frame: 12 weeks
Proportion of subjects undergoing lower-extremity amputation
Effect of topical pravibismane (MBN-101) suspension on the incidence of lower level extremity amputations
Time frame: 12 weeks
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