Diabetic Foot Infection Clinical Trial
Official title:
A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 in Patients With Moderate to Severe Diabetic Foot Infection (DFI)
Verified date | June 2020 |
Source | Microbion Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | July 26, 2019 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Limb Preservation Platform, Inc | Fresno | California |
United States | Futuro Clinical Trials, LLC | McAllen | Texas |
Lead Sponsor | Collaborator |
---|---|
Microbion Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with treatment-related adverse events | Safety and tolerability will be assessed by treatment-related adverse events | From the start of dosing upto 4 weeks following the completion of dosing | |
Primary | Proportion of participants who are clinically cured | Clinical cure is defined as the resolution of clinical signs and symptoms of infection 2 weeks following the end of treatment (EOT) | 2 weeks following completion of dosing (up to 5 weeks) | |
Secondary | Proportion of participants who are microbiologically cured | Microbiological cure is defined as the eradication of baseline pathogens 2 weeks following the end of treatment (EOT). | 2 weeks following completion of dosing (up to 5 weeks) |
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