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Topical Pravibismane for Diabetic Foot Infection
Phase 2
Waitlist Available
Led By Larry A Lavery, DPM,MPH
Research Sponsored by Microbion Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a new drug, MBN-101, to see if it is safe and works well to treat diabetic foot infection. MBN-101 will be applied to the skin, and patients will also receive antibiotics by mouth or through a vein.
Who is the study for?
This trial is for people with diabetes who have a moderate foot infection that's been there for at least 4 weeks. They should have had less than 36 hours of antibiotics or show that previous treatments didn't work, and their blood flow to the foot must be okay. People can't join if they have immune problems, are noncompliant with medical treatment, might use other remedies or therapies during the study, or if they've had certain cancers within the last 5 years.Check my eligibility
What is being tested?
The trial tests a new topical medicine called Pravibismane on diabetic foot infections alongside standard care. Patients will either get this new treatment three times a week for up to 12 weeks plus antibiotics (2 out of every 3 patients) or just standard care with antibiotics (1 out of every 3 patients).See study design
What are the potential side effects?
Possible side effects aren't specified in the provided information but could include skin reactions where Pravibismane is applied, given it's a topical medication. Standard antibiotic side effects may also occur such as stomach upset, rash, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with adverse events
Secondary outcome measures
Proportion of subjects undergoing lower-extremity amputation
Proportion of subjects with a clinical cure of infection
Proportion of subjects with complete wound closure
Trial Design
2Treatment groups
Experimental Treatment
Group I: Topical Pravibismane (MBN-101)Experimental Treatment1 Intervention
Topical 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.
Group II: Standard of CareExperimental Treatment1 Intervention
Standard of care treatment without administration of any topical drugs.
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Who is running the clinical trial?
CUBRC, MTEC, and US NavyUNKNOWN
Microbion CorporationLead Sponsor
2 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Diabetic Foot
52 Patients Enrolled for Diabetic Foot
Larry A Lavery, DPM,MPHPrincipal InvestigatorUTSW and Parkland Hospitals, Dallas TX
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an infection on my lower leg or foot, older than 4 weeks, needing surgery.I have an immune system disorder that is not being treated or controlled well.You have diabetes according to the American Diabetes Association criteria.I've had less than 36 hours of antibiotics for my ulcer, or they didn't work.I plan to use maggot therapy for my diabetic foot ulcer.I have a bone infection or it's highly suspected.I have an ulcer from Charcot joint disease.I plan to receive advanced cell therapies for my diabetic foot ulcer.My immune system is weak due to a condition like HIV, an autoimmune disease, or an organ transplant.I have multiple infected wounds on my foot due to diabetes.Your blood tests show high levels of creatinine, ALT, AST, or Alkaline Phosphatase, more than 3 times the normal range.I plan to undergo HBOT or NPWT for my diabetic foot ulcer.I am allergic to bismuth, methylcellulose, or Tween 80.I have been cancer-free for more than 5 years, except for non-melanoma skin cancer or treated cervical carcinoma-in-situ.I do not abuse alcohol or drugs that would interfere with my treatment.I will have surgery beyond basic wound care for my infection after joining.Your glycated hemoglobin level is higher than 12%.Your white blood cell count is too low.I am on dialysis for end-stage kidney disease.The blood flow in the affected limb is good, as shown by specific tests.
Research Study Groups:
This trial has the following groups:- Group 1: Topical Pravibismane (MBN-101)
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the trial permit inclusion of individuals over sixty years old?
"Hopeful participants in this medical research should be older than 18 but younger than 80 years old."
Answered by AI
Is this clinical trial currently accepting new participants?
"The clinical trial in question, initially posted on June 13th 2022 and lastly updated on August 29th 2022, is no longer actively seeking participants. Nevertheless, 895 other trials are presently looking for enrollees."
Answered by AI
Who meets the eligibility criteria to join this medical experiment?
"This clinical study is seeking 54 volunteers with diabetic foot who are aged 18-80 years old."
Answered by AI
Has MBN-101 acquired regulatory clearance as a topical application?
"The safety of MBN-101 topical has been estimated as a 2 on the 1 to 3 scale due its Phase 2 status. So far, there is prior data suggesting that it safe but none indicating efficacy."
Answered by AI
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