Multi-center Study to Assess Safety, Tolerability and Efficacy of MBN-101 in Patients With Moderate/Severe DFI

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open label, controlled study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied MBN-101 in hospitalized patients with diabetic foot infection. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Microbion Corporation
• Collaborator: CUBRC, MTEC, and US Navy

Criteria

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.