Diabetic Foot InfectionPhase 1NCT02723539
A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
A Phase 1 study testing MBN-101 in people with Diabetic Foot Infection, run by Microbion Corporation at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- MBN-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2017to 26 Jul 2019
- Phase
- Phase 1
- 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 75 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 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Limb Preservation Platform, Inc
Fresno, California, 93710
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
About this study
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)
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multi-center study that will be conducted in two parts. In Part I, patients will be enrolled into escalating dose cohorts (150, 375, or 600 µg/mL) (N=16/cohort) 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 with diabetes mellitus and a foot infection with an Infectious Disease Society of America (IDSA) infection severity rating of moderate or severe will be eligible for the trial. Both inpatients and outpatients are eligible if they meet all inclusion/exclusion criteria, however all enrolled patients must remain in-hospital for the first 24 hours after initial dosing. Patients with a need for surgical therapy (e.g., incision and drainage or removal of necrotic tissue) beyond standard bedside wound debridement should not be enrolled.
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. The determination to stop topical antibiotic therapy will be at the discretion of the principal investigator, and should be based on the resolution of findings of infection. All patients will also receive systemic antibiotic treatment based on the protocol defined algorithm. Systemic antibiotic therapy should continue until, but not beyond, the resolution of findings of infection, as outlined in the 2012 IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot infections,
- Conditions
- Diabetic Foot Infection
- Being tested
- MBN-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBN-101Drug
Also called BisEDT
Topical application
PlaceboDrug
Also called Vehicle
Topical application
| Study group | Role | What they receive |
|---|---|---|
| MBN-101 | Experimental | MBN-101: a suspension of 150, 375, or 600 microgram (µg)/milliliter (mL) (w:v) BisEDT drug particles in suspension in 3% methylcellulose / 0.5% polysorbate 80 / 10 millimole (mM) sodium chloride / 10 mM sodium phosphate. Receives: Drug: MBN-101 |
| Vehicle | Placebo comparator | MBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with treatment-related adverse events
Safety and tolerability will be assessed by treatment-related adverse events
Measured: From the start of dosing upto 4 weeks following the completion of dosing
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)
Measured: 2 weeks following completion of dosing (up to 5 weeks)
Secondary outcomes (1)
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).
Measured: 2 weeks following completion of dosing (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start6 Mar 2017
- Primary completion1 Nov 2017
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbion Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723539
- Sponsor's protocol ID
- MBN-101-202
- Status last verified
- Jun 2020
- First submitted
- 11 Mar 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipsky BA, Kim PJ, Murphy B, McKernan PA, Armstrong DG, Baker BHJ. Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double-blind, placebo-controlled trial. Int Wound J. 2024 Apr;21(4):e14817. doi: 10.1111/iwj.14817.
PubMed 38567778
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02723539
- Acronym / sponsor ID
- MBN-101-202
- Conditions
- Diabetic Foot Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Microbion CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, multi-center study that will be conducted in two parts. In Part I, patients will be enrolled into escalating dose cohorts (150, 375, or 600 µg/mL) (N=16/cohort) 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 with diabetes mellitus and a foot infection with an Infectious Disease Society of America (IDSA) infection severity rating of moderate or severe will be eligible for the trial. Both inpatients and outpatients are eligible if they meet all inclusion/exclusion criteria, however all enrolled patients must remain in-hospital for the first 24 hours after initial dosing. Patients with a need for surgical therapy (e.g., incision and drainage or removal of necrotic tissue) beyond standard bedside wound debridement should not be enrolled.
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. The determination to stop topical antibiotic therapy will be at the discretion of the principal investigator, and should be based on the resolution of findings of infection. All patients will also receive systemic antibiotic treatment based on the protocol defined algorithm. Systemic antibiotic therapy should continue until, but not beyond, the resolution of findings of infection, as outlined in the 2012 IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot infections,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBN-101 | Experimental | Drug: MBN-101MBN-101: a suspension of 150, 375, or 600 microgram (µg)/milliliter (mL) (w:v) BisEDT drug particles in suspension in 3% methylcellulose / 0.5% polysorbate 80 / 10 millimole (mM) sodium chloride / 10 mM sodium phosphate. |
| Vehicle | Placebo comparator | Drug: PlaceboMBN-101 diluent (placebo): 3% methylcellulose / 0.5% polysorbate 80 / 10 mM sodium chloride / 10 mM sodium phosphate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBN-101Also: BisEDTTopical application | Drug | MBN-101 |
| PlaceboAlso: VehicleTopical application | Drug | Vehicle |
Primary outcome
Proportion of participants with treatment-related adverse events
Time frame: From the start of dosing upto 4 weeks following the completion of dosing
Safety and tolerability will be assessed by treatment-related adverse events
Proportion of participants who are clinically cured
Time frame: 2 weeks following completion of dosing (up to 5 weeks)
Clinical cure is defined as the resolution of clinical signs and symptoms of infection 2 weeks following the end of treatment (EOT)
1 secondary outcome
Proportion of participants who are microbiologically cured
Time frame: 2 weeks following completion of dosing (up to 5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Derived from this study: PubMed 38567778Lipsky BA, Kim PJ, Murphy B, McKernan PA, Armstrong DG, Baker BHJ. Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double-blind, placebo-controlled trial. Int Wound J. 2024 Apr;21(4):e14817. doi: 10.1111/iwj.14817.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBN-101 in people with Diabetic Foot Infection, run by Microbion Corporation at 2 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 4 inclusion and 16 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 participants with treatment-related adverse events (time frame: From the start of dosing upto 4 weeks following the completion of dosing). The study lists 2 primary outcomes in all. 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 NCT02723539, which also lists 1 linked publication.
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 2 Jul 2020.