A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI

• Status: Completed
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Microbion Corporation

Criteria

Inclusion Criteria:

• Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria

• Has a foot infection as defined by the IDSA guidelines, with a severity rating of moderate or severe

• Either no current or recent (within 72 hours) antibiotic therapy for the DFI,

• Has documented adequate arterial perfusion in the affected limb (either palpable dorsalis pedis or posterior tibial pulses, or normal Doppler wave forms, or a toe blood pressure ≥ 45 mm Hg, or an ankle-brachial index (ABI) of >0.6)

Exclusion Criteria:

• Proven or highly suspected, involvement of bone (i.e., osteomyelitis)

• More than one concurrent, infected, diabetic foot ulcer

• Hemoglobin A1c > 11 on the day of presentation

• Requirement for ongoing immunosuppressive therapy (topical or inhaled corticosteroids are permitted)

• Serum creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase >2 times the upper limit of the normal range of the local testing laboratory

• Absolute neutrophil count <1000

• Any condition that has required treatment with any other bismuth containing compound within the last 2 weeks (i.e., Kaopectate or Pepto-Bismol)

• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months

• Need for any surgical therapy beyond debridement to treat the diabetic foot ulcer (e.g., incision and drainage, removal of necrotic tissue)

• Planned lower extremity amputation that will include their infected ulcer

• Known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80 (polysorbate 80))

• Female patients who are pregnant, lactating, or who have a positive serum human chorionic gonadotropin (pregnancy) as determined by laboratory testing

• Immunocompromised due to illness or organ transplant

• History of any type of cancer (excluding non-melanoma localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix)

• History of major medical noncompliance

• Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results