Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study (BBR-012)

December 22, 2011 updated by: Bridge BioResearch Ltd.

A Randomised, Double-Blind, Repeat-Dose, Placebo-Controlled Phase IIa Proof of Concept Study to Investigate the Safety and Efficacy of Oral BBR-012 in Combination With Standard Medical Care in Diabetic Patients With Complicated Skin Ulceration on the Foot (Diabetic Foot Ulcer)

The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Ashton-under-Lyne, United Kingdom, OL6 9RW
        • Recruiting
        • Tameside Hospital NHS Foundation Trust
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • Bradford Royal Infirmary , Bradford Teaching Hospitals NHS Trust
      • Cardiff, United Kingdom, CF14 4XN
        • Recruiting
        • Department of Wound Healing, School of Medicine, Cardiff University
      • Chorley, United Kingdom, PR7 1PP
        • Recruiting
        • Chorley & South Ribble Hospital, Lancashire Teaching Hospitals Trust
      • Croydon, United Kingdom, CR7 7YE
        • Recruiting
        • Croydon University Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh, Lothian University Hospital Trust
      • Gloucester, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucester Royal Hospital NHS Foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester Royal Infirmary, University Department of Medicine
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital, Plymouth Hospitals NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Aged ≥18
  • Diabetes mellitus
  • Ischaemic or neuro-ischaemic Diabetic Foot Ulcer below the malleolus, but not wholly on the sole of the foot (minimum size: 1 cm x 1 cm)
  • Body Mass Index(BMI) ≤40 kg/m2
  • Women of childbearing potential must use acceptable methods of birth control
  • Written informed consent to participate in the study
  • Patients must be able to speak English fluently and to understand English

Main Exclusion Criteria:

  • Any uncontrolled illnesses (e.g. active malignancy, vasculitis) that, in the opinion of the investigator, would interfere with interpreting the results of the study
  • Infected Diabetic Foot Ulcer based on the IDSA guidelines, i.e. presence of purulent secretions or at least two of the manifestations of inflammation (erythema, warmth, swelling or induration and pain or tenderness), and for whom, in the investigator's judgment, intravenous or oral antibiotic therapy is required
  • Active osteomyelitis
  • Wholly plantar Diabetic Foot Ulcer
  • Suspected gangrenous tissue of the affected limb that cannot be removed with a single debridement
  • Diabetic Foot Ulcer associated with prosthetic material or a device
  • Received any potentially effective systemic antibiotic therapy for more than 24 hours during the 72-hour period before the screening visit
  • Is receiving, or has received within the 14 days prior to the screening visit, any concomitant topical wound therapy (e.g., topical antimicrobial therapy, topical debriding agent, topical growth factor, topical skin replacement, or hyperbaric oxygen)
  • Has received systemic corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within the 30 days prior to the screening visit.
  • Hepatic impairment, renal impairment (defined as estimated glomerular filtration rate <10 mL/minute/1.73m2), hypersensitivity to isoniazid.
  • High risk for tuberculosis, e.g. HIV positive, are immunosuppressed, or have active malignancy
  • Symptoms of active or latent tuberculosis (based on specific history, physical examination, Interferon Gamma Release Assay (IGRA) test and chest X-Ray)
  • Known or suspected drug or alcohol abuse or positive drugs of abuse test.
  • Participating in any clinical study the 12 weeks before the screening visit
  • Donation of more than 450 mL of blood in the 3 months before the screening visit, or 1200 mL blood in the 12 months before the screening visit.
  • History of severe hypersensitivity or ongoing hypersensitivity that might affect the patient's suitability for the study (e.g. hypersensitivity to wound dressings), as judged by the investigator.
  • History of allergy to, or insensitivity to, local anaesthetics
  • Use of any prescribed or non-prescribed (over-the-counter) medication, including herbal medication (e.g., St. Johns Wort) that could possibly interfere with the objectives of this study (e.g., could affect the closure of chronic dermal ulceration), during 2 weeks (or 5 half-lives of the compound whichever is the longer) before the anticipated first dose of study medication. Occasional paracetamol for pain relief (maximum 2 g per 24 hours) and adrenergic nasal spray for relief of nasal congestion are allowed
  • Having received BBR-012 or isoniazid within the 6 months prior to the screening visit
  • Bleeding disorder or history of increased bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: placebo
tablets, dosing 3 times daily, 12 weeks
Experimental: BBR-012
Drug: isoniazide
Tablets, dosing 3 times daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of healing of diabetic foot ulcers (% reduction in area from baseline)
Time Frame: 4, 8 and 12 weeks
4, 8 and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of healing (change from baseline) as assessed by various scoring criteria: IDSA, modified ASEPSIS score, TEXAS Diabetic wound score, composite severity score and global clinical assessment
Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up)
week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up)
Effect of BBR-012 on the level of ischemia (change from baseline as measured by tcpO2)
Time Frame: 4, 8 and 12 weeks
4, 8 and 12 weeks
Effect of BBR-012 on microbiological outcome (presence of pathogens and outcome as compared to baseline)
Time Frame: week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up)
week 1, 2, 3, 4, 6, 8, 10, 12 and 13-14(follow up)
Safety and tolerability of BBR-012 as assessed by reported adverse events and safety laboratory parameters
Time Frame: from baseline visit to week 14
from baseline visit to week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bridge BioResearch Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew J Boulton, Professor, Manchester Royal Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBR-012CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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