Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
- Conditions
- Diabetic Foot InfectionDiabetic Foot
- Registration Number
- NCT05174806
- Lead Sponsor
- Microbion Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Has diabetes mellitus, according to the American Diabetes Association (ADA)<br> criteria.<br><br> - Has a skin ulcer located on or distal to the malleolus that is = 4 weeks that is<br> clinically documented, and presents with clinical manifestations of a moderate<br> infection (i.e. erythema extending = 2.0 cm from the wound margin), and not<br> requiring hospitalization.<br><br> - Has received no more than 36 hours of antibiotic therapy for the moderately infected<br> ulcer prior to enrollment or there is clinical and/or microbiological evidence of<br> failure of antibiotic treatment for the treatment of the moderately infected ulcer.<br><br> - Has documented adequate arterial perfusion in the affected limb by biphasic or<br> triphasic Doppler wave forms, a toe brachial index (TBI) =0.75, or an ankle brachial<br> index (ABI) of >0.9).<br><br> - Has read and signed the Informed Consent Form (ICF) after the nature of the study<br> has been fully explained.<br><br>Exclusion Criteria:<br><br> - Has proven or highly suspected, involvement of bone (i.e., osteomyelitis).<br><br> - Has an ulcer due to Charcot arthropathy.<br><br> - Has more than one concurrent, infected, diabetic foot wound on the study limb.<br><br> - Is unwilling or unable to attend clinic visits and keep research appointments.<br><br> - Is unwilling or unable to adhere to the systemic antibiotic treatment prescribed.<br><br> - Is unwilling or unable to adhere to proper pressure off-loading of the foot wound<br> (when needed) from enrollment through EOS as directed by the treating physician.<br><br> - Has an untreated, uncontrolled, or poorly managed immunosuppressive and or<br> autoimmune disorder.<br><br> - Plans to use any topical antibiotics, herbals remedies (e.g., honey), alternative<br> medicines or antimicrobials, either directly or by dressings on their infected DFU<br> at any time from enrollment through the EOS visit.<br><br> - Plans to receive treatment with larvae (maggots) for their infected DFU at any time<br> from enrollment through the EOS visit.<br><br> - Plans to receive treatment with advanced cellular therapies (e.g., Platelet-derived<br> growth factor (PDGF), Cellular Tissue Products (CTP), granulocyte colony-stimulating<br> factor (G CSF)) for their infected DFU at any time from enrollment through the EOS<br> visit.<br><br> - History of major medical noncompliance.<br><br> - Any condition that has required treatment with any other bismuth containing compound<br> within 2 weeks prior to enrollment through EOS visit (i.e., Kaopectate or<br> Pepto-Bismol, including topical applications such as Xeroform).<br><br> - Plans to receive treatment with Hyperbaric oxygen therapy (HBOT) or topical negative<br> pressure wound therapy (NPWT) for their infected DFU at any time from enrollment<br> through the EOS visit.<br><br> - Glycated hemoglobin >12%.<br><br> - Has a serum creatinine, ALT, AST or Alkaline Phosphatase >3 times the upper limit of<br> the normal range of the local testing laboratory.<br><br> - End stage renal disease requiring dialysis.<br><br> - Has an absolute neutrophil count <1000.<br><br> - Has participated in an investigational trial to evaluate pharmaceuticals or<br> biologics either concurrently or within the past 30 days.<br><br> - Will undergo a planned surgical therapy beyond standard bedside debridement or<br> incision and drainage, to treat the DFI after enrollment.<br><br> - Has a known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80<br> (polysorbate 80)).<br><br> - Is immunocompromised and not well-managed due to illness [human immunodeficiency<br> virus (HIV), autoimmune disease] or organ transplant.<br><br> - Has a history of any type of cancer (excluding non-melanoma localized skin cancer or<br> completely excised and cured carcinoma-in-situ of uterine cervix) unless the subject<br> has been free of cancer for > 5 years.<br><br> - Developmental disability/significant psychological disorder that in the opinion of<br> the investigator could impair the subject's ability to provide informed consent,<br> participate in the study protocol or record study measures.<br><br> - Active alcohol abuse (> 14 drinks per week over the last 3 months) or substance<br> abuse (current use of cocaine, heroin, or methamphetamines) or if drug or alcohol<br> use will interfere with visits in clinic in the opinion of the investigator.<br><br> - Has other medical condition(s) which, in the opinion of the Principal Investigator,<br> would jeopardize the safety of the study subject or impact the validity of the study<br> results.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with adverse events
- Secondary Outcome Measures
Name Time Method Proportion of subjects with complete wound closure;Proportion of subjects with a clinical cure of infection;Proportion of subjects undergoing lower-extremity amputation