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BB-101 for Treatment of Diabetic Lower Leg and Foot Ulcers

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.
 
ClinicalTrials.gov Identifier: NCT03888053
Recruitment Status : Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Blue Blood Biotech Corp.

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE March 28, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Incidence and severity of local reactions [ Time Frame: 6 weeks ]
    To assess the incidence of local reactions for target ulcer and surrounding area and record the severity
  • Incidence and severity of adverse events [ Time Frame: 6 weeks ]
    To assess the incidence of adverse events and record the severity
  • Incidence of clinical laboratory abnormalities [ Time Frame: 6 weeks ]
    To assess the incidence of clinical laboratory abnormalities
  • Change from baseline in ECG [ Time Frame: 6 weeks ]
    To assess the change of baseline in ECG
  • Change from baseline in blood pressure [ Time Frame: 6 weeks ]
    To assess the change of baseline in in blood pressure
  • Change from baseline in heart rate [ Time Frame: 6 weeks ]
    To assess the change of baseline in heart rate
  • Change from baseline in body temperature [ Time Frame: 6 weeks ]
    To assess the change of baseline in body temperature
  • Presence of anti-BB-101 antibodies [ Time Frame: 6 weeks ]
    To assess the immunogenecity for BB-101
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Proportion of subjects with target ulcer that heals within the 4-week treatment period [ Time Frame: 4 weeks ]
    complete healing defined as re-epithelialization without drainage and dressing requirement
  • To evaluate plasma concentration of BB-101 [ Time Frame: 4 weeks ]
    To evaluate plasma concentration of BB-101
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BB-101 for Treatment of Diabetic Lower Leg and Foot Ulcers
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Topical BB-101 (rhNEGF) for the Treatment of Diabetic Lower Leg and Foot Ulcers
Brief Summary This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.
Detailed Description

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.

The study will be conducted at multiple investigational sites located in Taiwan. Additional sites and countries may be added during the course of the study if required.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Biological: BB-101
Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.
Study Arms  ICMJE
  • Active Comparator: BB-101 Treatment Arm
    BB-101 liquid formulation concentration of 2 µg/mL or 20 µg/mL will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks.
    Intervention: Biological: BB-101
  • Placebo Comparator: Placebo Arm
    Placebo will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks.
    Intervention: Biological: BB-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2021)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
36
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 20 years of age and older.
  • Type 1 or type 2 diabetes mellitus.
  • Glycosylated hemoglobin (HbA1c) of ≤12%.
  • A target ulcer on the lower leg or foot that meets the following criteria at screening:

    1. located below knees,
    2. Area of 0.5 - 10.0 cm^2 following sharp debridement , as measured at Visit 1 and confirmed at Visit 2,
    3. Extending through the epidermis and dermis but not involving bone, tendon or ligament,
    4. Present for ≥4 weeks prior to Visit 1 despite appropriate care, and
    5. Ulcer without clinical signs and symptoms of infection.
  • Adequate arterial blood supply to the lower leg or foot under study, to be measured either by doppler ultrasonography, ankle brachial pressure index (ABPI) ≥0.70, or toe pressure >30 mmHg.
  • Female subjects of childbearing potential must have a negative serum pregnancy test prior to first dose of study medication and must agree to use an effective method of contraception throughout the study. Females who are surgically sterile or have been postmenopausal for at least 1 year (12 consecutive months without menses) are exempted from these criteria. Effective methods of contraception include oral contraceptives, injectable or implantable hormonal methods, intrauterine devices, tubal ligation (if performed more than 1 year prior to screening), or double barrier contraception (e.g., diaphragm+condom).
  • Subject agrees to comply with ulcer care regimen for the duration of the study.
  • Subject is able to understand and sign an informed consent form and willing to comply with all study procedures.

Exclusion Criteria:

  • Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation (the presence of infection is defined by ≥2 classic findings of inflammation or purulence).
  • Presence of cellulitis or gangrene on the lower leg or foot under study.
  • Presence of another open ulcer <2 cm away from target ulcer, on the same lower leg or foot.
  • Target ulcer on the heel.
  • Target ulcer caused primarily by untreated arterial insufficiency or with an etiology not related to diabetes.
  • Subjects with ulcers related to an incompletely healed amputation wound.
  • Acute or chronic osteomyelitis affecting the area of the target ulcer.
  • Any structural deformity of the lower leg or foot under study that would prevent off- loading of the target ulcer, including acute Charcot osteoarthropathy.
  • Previous use of a platelet-derived product (e.g., becaplermin) or other growth factors on the target ulcer within 4 weeks prior to Visit 1.
  • Previous use of autologous graft or allogeneic graft, or dermal substitute or living skin equivalent (e.g., Dermagraft® or Apligraf®) on the target ulcer or hyperbaric oxygen therapy within 2 weeks prior to Visit 1.
  • Use of any topical antimicrobials or enzymatic debridement treatment, to treat the target ulcer within 7 days prior to Visit 1.
  • Treatment with systemic corticosteroids other than for inhalation, immunosuppressive agents, radiation therapy, or chemotherapeutic agent within 30 days prior to Visit 1 or likelihood to receive any of these therapies during study participation.
  • History of cancer or current cancer, with the exception of adequately treated or excised non-melanoma skin cancer.
  • Vasculitis, connective tissue diseases, or any medical conditions known to impair ulcer healing, other than diabetes.
  • Sickle cell disease.
  • Clinically significant electrocardiogram (ECG) abnormality, as determined by the Investigator.
  • Any of the following laboratory results at screening: serum creatinine >2.5 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x upper limit of normal (ULN).
  • Poor nutritional status (serum albumin < 2.5 g/dL).
  • A history of drug or alcohol abuse that could compromise compliance or safety.
  • History of human immunodeficiency virus (HIV) infection.
  • Known sensitivity to any component of BB-101 or placebo.
  • Participation in a clinical trial of an investigational drug or device within 30 days of study entry.
  • Pregnancy, lactation, or plans to become pregnant within 6 months.
  • Any social or medical condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  • History of non-compliance with treatment or clinical visit attendance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03888053
Other Study ID Numbers  ICMJE BB-101-001A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Blue Blood Biotech Corp.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Blue Blood Biotech Corp.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shih-Chen Pan, MD National Cheng-Kung University Hospital
PRS Account Blue Blood Biotech Corp.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP