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Diabetic Foot InfectionPhase 2NCT05174806

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

A Phase 2 study testing Topical Pravibismane in people with Diabetic Foot Infection and Diabetic Foot, run by Microbion Corporation at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diabetic Foot Infection, Diabetic Foot
What is being tested?
Topical Pravibismane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
7 sitesUnited States
Study dates
13 Jun 2022to 19 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
  • Has a skin ulcer located on or distal to the malleolus that is ≥ 4 weeks that is clinically documented, and presents with clinical manifestations of a moderate infection (i.e. erythema extending ≥ 2.0 cm from the wound margin), and not requiring hospitalization.
  • Has received no more than 36 hours of antibiotic therapy for the moderately infected ulcer prior to enrollment or there is clinical and/or microbiological evidence of failure of antibiotic treatment for the treatment of the moderately infected ulcer.
  • Has documented adequate arterial perfusion in the affected limb by biphasic or triphasic Doppler wave forms, a toe brachial index (TBI) ≥0.75, or an ankle brachial index (ABI) of >0.9).
  • Has read and signed the Informed Consent Form (ICF) after the nature of the study has been fully explained.

Who cannot join

  • Has proven or highly suspected, involvement of bone (i.e., osteomyelitis).
  • Has an ulcer due to 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.
Show all 25Show fewer
  • Has an untreated, uncontrolled, or poorly managed immunosuppressive and or autoimmune disorder.
  • 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.
  • History of major medical noncompliance.
  • 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.
  • Has participated in an investigational trial to evaluate pharmaceuticals or biologics either concurrently or within the past 30 days.
  • Will undergo a planned surgical therapy beyond standard bedside debridement or incision and drainage, to treat the DFI after enrollment.
  • Has a known allergy to bismuth and/or MBN-101 excipients (methylcellulose, Tween 80 (polysorbate 80)).
  • Is immunocompromised and not well-managed due to illness [human immunodeficiency virus (HIV), autoimmune disease] or organ transplant.
  • Has a history of any type of cancer (excluding non-melanoma localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix) unless the subject has been free of cancer for > 5 years.
  • Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures.
  • Active alcohol abuse (> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroin, or methamphetamines) or if drug or alcohol use will interfere with visits in clinic in the opinion of the investigator.
  • Has other medical condition(s) which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Parkland Comprehensive Wound Center

    Dallas, Texas, 75235

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • University of Texas Southwestern Medical Center University Wound Care Clinic

    Dallas, Texas, 75390

  • University of Texas Southwestern Medical Center William P. Clements Jr. University Hospital

    Dallas, Texas, 75390

  • Limb Preservation Platform, Inc.

    Fresno, California, 93710

  • Futuro Clinical Trials, LLC

    McAllen, Texas, 78501

  • Bio-X-Cell Research

    San Antonio, Texas, 78224

Other trials in United States

About this study

Official title: A Randomized, Open Label, Controlled, Phase 2, Multi-Center Study to Assess Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 (Pravibismane Topical Suspension) in Subjects With Moderate Diabetic Foot Infection (DFI)

This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

Read the detailed 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 International Working Group Diabetic Foot (IWGDF) severity rating of moderate 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 the MBN-101 arm will be treated in an outpatient facility 3 times per week for the first 2 weeks. During each of the subsequent 10 weeks, patients will be treated once per week at the outpatient clinic and will be provided with enough MBN-101 for 2 additional days of treatment for self administration at home with or without the assistance of a caregiver. The duration between each dose should be greater than 24 hours, yet not exceed 72 hours for each of the 12 treatment weeks. Patients randomized to the standard of care arm will follow the same schedule (i.e., inclusive of wound dressing changes), though will not be treated with MBN-101.

All subjects will initially 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, yet part of the standard of care treatment.

Being tested
Topical Pravibismane, Standard of Care
Keywords
Amputation, DFI, Wound closure, Diabetic Foot Infection, Pravibismane, Clinical Cure, Safety and tolerability
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical PravibismaneDrug

    Also called MBN-101

    Topical Pravibismane

  • Standard of CareOther

    Also called SOC comparator

    Standard of care treatment without investigational topical pravibismane (MBN-101) or other topical antibiotics.

Study groups in NCT05174806
Study groupRoleWhat they receive
Topical Pravibismane (MBN-101)ExperimentalTopical pravibismane (MBN-101) at a dose of 2.5 mg/mL will be applied directly to the infected wound and covered with an appropriate non-antimicrobial dressing. Dosing will occur 3 times per week for the 12 weeks of treatment.
Receives: Drug: Topical Pravibismane
Standard of CareOtherStandard of care treatment without administration of any topical drugs.
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with adverse events

    Safety and tolerability

    Measured: 12 weeks

Secondary outcomes (3)

  1. Proportion of subjects with complete wound closure

    Effect of MBN-101 suspension on wound healing

    Measured: 12 weeks

  2. Proportion of subjects with a clinical cure of infection

    Effect of MBN-101 suspension on resolution of infection

    Measured: 12 weeks

  3. Proportion of subjects undergoing lower-extremity amputation

    Effect of topical pravibismane (MBN-101) suspension on the incidence of lower level extremity amputations

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2022
  2. Study start13 Jun 2022
  3. Primary completion19 Jan 2024
  4. Study completion19 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Topical Pravibismane (MBN-101) versus Standard of Care (SOC); 2:1 ratio.
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174806
Sponsor's protocol ID
MBN-101-203
Status last verified
Oct 2024
First submitted
14 Dec 2021
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical Pravibismane in people with Diabetic Foot Infection and Diabetic Foot, run by Microbion Corporation at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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