Diabetic Foot UlcerPhase 1NCT03888053
BB-101 for Treatment of Diabetic Lower Leg and Foot Ulcers
A Phase 1 study testing BB-101 in people with Diabetic Foot Ulcer, run by Blue Blood Biotech Corp. at 6 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- BB-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 6 sitesTaiwan
- Study dates
- 28 Mar 2018to 31 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- located below knees,
- Area of 0.5 - 20.0 cm^2 following sharp debridement , as measured at Visit 1 and confirmed at Visit 2,
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- Extending through the epidermis and dermis and may have reached bone, tendon or joint capsule (Grade 1 to grade 2 according to Wagner Classification System for diabetic foot ulcer),
- Present for ≥4 weeks prior to Visit 1 despite appropriate care, and
- 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) ≥0.50, or toe pressure >30 mmHg.
- Note: For subjects with 0.7>ABPI ≧0.5, adequate treatments must be provided to the subject for improving circulation by medication or surgical procedures, etc. ABPI is the ratio of the highest systolic blood pressure of the dorsalis pedis or posterior tibial arteries of each leg to the highest of the left and right arm brachial systolic blood pressure.
- 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.
Who cannot join
- 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.
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- 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 basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to administration of any study agent).
- 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, including but not limited to:
- QTc ≥450 ms in male subject or ≥460 ms in female subject at screening
- Significant ST-segment-T wave (ST-T) changes or left bundle branch block (LBBB)
- Any unstable cardiovascular disease, as determined by the Investigator, that renders the subject inappropriate for participating the study, including but not limited to:
- Has a history of, or concurrent congestive heart failure (CHF) defined by New York Heart Association (NYHA) Classes III or IV.
- Myocardial infarction (MI), unstable angina, percutaneous coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening. Subjects with adequately treated stable angina, per physician investigator's assessment, may be included.
- 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 drug administration.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
E-DA Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Shuangho Hospital
New Taipei City
National Cheng Kung University Hospital
Tainan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- BB-101
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-101Biological
Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| BB-101 Treatment Arm | Active comparator | 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. Receives: Biological: BB-101 |
| Placebo Arm | Placebo comparator | Placebo will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks. Receives: Biological: BB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of local reactions
To assess the incidence of local reactions for target ulcer and surrounding area and record the severity
Measured: 6 weeks
Incidence and severity of adverse events
To assess the incidence of adverse events and record the severity
Measured: 6 weeks
Incidence of clinical laboratory abnormalities
To assess the incidence of clinical laboratory abnormalities
Measured: 6 weeks
Change from baseline in ECG
To assess the change of baseline in ECG
Measured: 6 weeks
Change from baseline in blood pressure
To assess the change of baseline in in blood pressure
Measured: 6 weeks
Change from baseline in heart rate
To assess the change of baseline in heart rate
Measured: 6 weeks
Change from baseline in body temperature
To assess the change of baseline in body temperature
Measured: 6 weeks
Presence of anti-BB-101 antibodies
To assess the immunogenecity for BB-101
Measured: 6 weeks
Secondary outcomes (2)
Proportion of subjects with target ulcer that heals within the 4-week treatment period
complete healing defined as re-epithelialization without drainage and dressing requirement
Measured: 4 weeks
To evaluate plasma concentration of BB-101
To evaluate plasma concentration of BB-101
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start28 Mar 2018
- Primary completion1 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Blood Biotech Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shih-Chen Pan, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888053
- Sponsor's protocol ID
- BB-101-001A
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2019
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03888053
- Acronym / sponsor ID
- BB-101-001A
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Blue Blood Biotech Corp.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BB-101 Treatment Arm | Active comparator | Biological: BB-101BB-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. |
| Placebo Arm | Placebo comparator | Biological: BB-101Placebo will be applied on the target lower leg or foot ulcer once a day for 4 consecutive weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Adequate arterial blood supply to the lower leg or foot under study, to be measured either by doppler ultrasonography, ankle brachial pressure index (ABPI) ≥0.50, or toe pressure >30 mmHg.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-101Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo. | Biological | BB-101 Treatment Arm, Placebo Arm |
Primary outcome
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
2 secondary outcomes
Proportion of subjects with target ulcer that heals within the 4-week treatment period
Time frame: 4 weeks
To evaluate plasma concentration of BB-101
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Chen Pan, MD principal investigator
National Cheng-Kung University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BB-101 in people with Diabetic Foot Ulcer, run by Blue Blood Biotech Corp. at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of local reactions (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.