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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342497
Recruitment Status : Unknown
Verified December 2011 by Bridge BioResearch Ltd..
Recruitment status was:  Recruiting
First Posted : April 27, 2011
Last Update Posted : December 23, 2011
Information provided by (Responsible Party):
Bridge BioResearch Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: isoniazide Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BBR-012 Drug: isoniazide
Tablets, dosing 3 times daily, 12 weeks

Placebo Comparator: Placebo Drug: placebo
tablets, dosing 3 times daily, 12 weeks

Primary Outcome Measures :
  1. Rate of healing of diabetic foot ulcers (% reduction in area from baseline) [ Time Frame: 4, 8 and 12 weeks ]

Secondary Outcome Measures :
  1. 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) ]
  2. Effect of BBR-012 on the level of ischemia (change from baseline as measured by tcpO2) [ Time Frame: 4, 8 and 12 weeks ]
  3. 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) ]
  4. Safety and tolerability of BBR-012 as assessed by reported adverse events and safety laboratory parameters [ Time Frame: from baseline visit to week 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01342497

Contact: Andrew Boulton, Professor 0161 276 4406

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

Responsible Party: Bridge BioResearch Ltd. Identifier: NCT01342497     History of Changes
Other Study ID Numbers: BBR-012CS01
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by Bridge BioResearch Ltd.:
diabetic foot ulcer

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases