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

  • STATUS
    Recruiting
  • End date
    Jul 20, 2023
  • participants needed
    54
  • sponsor
    Microbion Corporation
Updated on 20 July 2022
diabetes
antibiotics
diabetic foot
foot infection
diabetic foot infection

Summary

This is a randomized, open label, controlled study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in hospitalized patients with diabetic foot infection. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied once daily for the first week of treatment and three times per week for up to 11 additional weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

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 infectious Diseases Society of America (IDSA) severity rating of moderate to severe requiring hospitalization 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 active treatment will receive topical pravibismane (MBN-101) once daily for the first week while hospitalized and then three times for up to 11 additional weeks as an outpatient. The period between doses should be greater than 24 hours and not exceed 72 hours. Patients randomized to the standard of care arm will only receive standard of care and will not receive MBN-101.

All patients will 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, as part of the standard of care treatment.

Patients will return to the clinic for dressing changes and re-application of MBN-101 weekly after discharge from the hospital. The patient or patient's caregiver will apply MBN-101 two times per week at home in between visits.

Details
Condition Diabetic Foot Infection, Diabetic Foot
Treatment Standard of Care, MBN-101 topical, Topical Pravibismane
Clinical Study IdentifierNCT05174806
SponsorMicrobion Corporation
Last Modified on20 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria
Has an infection located on or distal to the malleolus where the excision post-surgically measures 3-20 cm2 and presents with clinical manifestations of a moderate or severe infection
Requires hospitalization for the treatment of their moderate to severe infected wound
Has documented adequate arterial perfusion in the affected limb (either normal biphasic or triphasic doppler waveforms, or a toe pressure > 30 mmHg, or an ankle brachial index (ABI) of ≥0.7)

Exclusion Criteria

Has proven or highly suspected, involvement of bone (i.e., osteomyelitis) as determined by a positive bone culture, positive bone histopathology and/or MRI of lower extremity. If suspected or proven osteomyelitis has been surgically removed and clean margins are present, the patient can be enrolled
Active 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 a requirement for ongoing immunosuppressive therapy (topical or inhaled corticosteroids are permitted)
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
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
End stage renal disease requiring dialysis
Has an absolute neutrophil count <1000\
Will undergo a planned surgical therapy beyond standard bedside debridement or incision and drainage, to treat the DFI after enrollment
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