Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study
NCT ID: NCT01342497
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2011-07-31
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BBR-012
isoniazide
Tablets, dosing 3 times daily, 12 weeks
Placebo
placebo
tablets, dosing 3 times daily, 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
isoniazide
Tablets, dosing 3 times daily, 12 weeks
placebo
tablets, dosing 3 times daily, 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bridge BioResearch Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew J Boulton, Professor
Role: PRINCIPAL_INVESTIGATOR
Manchester Royal Infirmary
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, , United Kingdom
Bradford Royal Infirmary , Bradford Teaching Hospitals NHS Trust
Bradford, , United Kingdom
Department of Wound Healing, School of Medicine, Cardiff University
Cardiff, , United Kingdom
Chorley & South Ribble Hospital, Lancashire Teaching Hospitals Trust
Chorley, , United Kingdom
Croydon University Hospital
Croydon, , United Kingdom
Royal Infirmary of Edinburgh, Lothian University Hospital Trust
Edinburgh, , United Kingdom
Gloucester Royal Hospital NHS Foundation Trust
Gloucester, , United Kingdom
Manchester Royal Infirmary, University Department of Medicine
Manchester, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Derriford Hospital, Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Southampton Hospitals NHS Trust
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BBR-012CS01
Identifier Type: -
Identifier Source: org_study_id