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

NCT01342497 | Unknown Phase 2 DMC

• 1 other identifier: BBR-012CS01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

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.

Conditions

Diabetic Foot Ulcer

Keywords

diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Rate of healing of diabetic foot ulcers (% reduction in area from baseline)

  4, 8 and 12 weeks

Secondary Outcomes (4)

• 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

  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)

  4, 8 and 12 weeks

• Effect of BBR-012 on microbiological outcome (presence of pathogens and outcome as compared to baseline)

  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

  from baseline visit to week 14

Study Arms (2)

BBR-012

EXPERIMENTAL

Drug: isoniazide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

isoniazide DRUG

Tablets, dosing 3 times daily, 12 weeks

BBR-012

placebo DRUG

tablets, dosing 3 times daily, 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bridge BioResearch Ltd.: lead

Study Sites (11)

Tameside Hospital NHS Foundation Trust

Ashton-under-Lyne, OL6 9RW, United Kingdom

RECRUITING

Bradford Royal Infirmary , Bradford Teaching Hospitals NHS Trust

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Department of Wound Healing, School of Medicine, Cardiff University

Cardiff, CF14 4XN, United Kingdom

RECRUITING

Chorley & South Ribble Hospital, Lancashire Teaching Hospitals Trust

Chorley, PR7 1PP, United Kingdom

RECRUITING

Croydon University Hospital

Croydon, CR7 7YE, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh, Lothian University Hospital Trust

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Gloucester Royal Hospital NHS Foundation Trust

Gloucester, GL1 3NN, United Kingdom

RECRUITING

Manchester Royal Infirmary, University Department of Medicine

Manchester, M13 9WL, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Derriford Hospital, Plymouth Hospitals NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Southampton Hospitals NHS Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Andrew J Boulton, Professor

  Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Boulton, Professor

CONTACT

0161 276 4406; aboulton@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 27, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

GB (11)