Diabetic Foot UlcerPhase 2NCT06383013
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
A Phase 2 study testing BB-101 in people with Diabetic Foot Ulcer, run by Blue Blood Biotech Corp. at 5 sites in Taiwan.
Trial summary
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer. 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
- 96 participants
- Where
- 5 sitesTaiwan
- Study dates
- 1 May 2024to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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, at least 20 years of age (inclusive) at the date of Screening
- Subject or legally authorized representative who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
- Subject agrees to comply with ulcer care regimen for the duration of the study and is willing to return for all mandatory visits as defined in the protocol
- Subject with Type 1 or Type 2 diabetes mellitus (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) and is under the care of a physician for the management of diabetes mellitus
- Subject with glycosylated hemoglobin (HbA1c) ≤ 12%
- Subject with at least one diabetic foot ulcer meets the following criteria at Screening
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- Visit:
- Located below knees; ii. Not healing for ≥ 4 weeks prior to Screening Visit despite appropriate care; iii. Ulcer size of ≥ 0.5 cm2 to ≤ 10 cm2 measured by the electronic measuring device following sharp debridement (if necessary) at Screening Visit and reconfirmed at Randomization Visit; iv. The largest ulcer will be selected as target ulcer. If ≥ 2 ulcers have the largest size, the one with the worst grade by Wagner Classification will be selected. If ≥ 2 ulcers have the largest size and grade, the one with longest duration will be selected; v. The target ulcer is classified as Grade 1 to Grade 2 according to Wagner Classification System for diabetic foot ulcer; vi. The target ulcer should be without clinical signs and symptoms of infection
- Subject with adequate circulation to the affected lower limb, as demonstrated by at least one of the following criteria: i. Dorsum transcutaneous oximetry (TcPO2) ≥ 30 mmHg ii. Ankle brachial pressure index (ABPI) ≥ 0.7 iii. Absolute toe blood pressure > 30 mmHg iv. Doppler ultrasonography showed < 75% stenosis in the lower extremity arteries
- Subject with adequate hepatic (ALT and AST ≤ 2 × ULN) and renal function (Serum creatinine ≤ 3 mg/dL)
- Subject with adequate hematology function:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL ii. Total white blood cell (WBC) ≥ 3,000 cells/μL iii. Platelets ≥ 100,000 counts/μL iv. Hemoglobin ≥ 10 g/dL for male, ≥ 9 g/dL for female
- Female subjects show negative serum pregnancy test results within 28 days prior to the first study treatment.
- All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods during dosing and for at least 4 weeks after stopping study treatment.
Who cannot join
- Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation.
- The presence of infection is defined by ≥ 2 of the items presented as:
- Local swelling or induration
- Erythema > 0.5 cm around wound
- Local tenderness or pain
- Local increased warmth
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- Purulent discharge
- Subject with cellulitis or gangrene on the lower leg or foot with the target ulcer
- Subject with active osteomyelitis, which requires systemic antibiotics. Systemic antibiotics must be complete or discontinued 1 week prior to Screening Visit.
- With target ulcer size decreased or increased by at least 30% after receiving 2 weeks of standard-of-care for diabetic foot ulcer before Randomization visit
- Subject with another open ulcer < 2 cm away from target ulcer, on the same lower leg or foot
- Subject with target ulcer caused primarily by etiologies not related to diabetes
- Subject with target ulcers related to an incompletely healed amputation wound
- Subject with any structural deformity of the lower leg or foot under study that would prevent off-loading of the target ulcer; subject with conditions which may interfere the off-loading effect may be excluded by the Investigators' judgment
- Subject is scheduled to (or has received within 4 weeks prior to Screen Visit) receive any of the following medications or treatments:
- Platelet-derived product (e.g., becaplermin) or other growth factors on the target ulcer
- Systemic corticosteroids (other than for inhalation), immunosuppressive agents, radiation therapy, or chemotherapeutic agents
- Participation in a clinical trial of an investigational drug or device
- 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 Screening Visit
- Use of any topical antimicrobials or enzymatic debridement treatment to treat the target ulcer within 7 days prior to Screening Visit
- Subject with 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
- Subject diagnosed with sickle cell disease
- Subject with clinically significant electrocardiogram (ECG) abnormality, as determined by the Investigator
- Poor nutritional status (serum albumin < 2.5 g/dL)
- C-reactive protein (CRP) > 50 mg/dL
- Subject had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.
- Patient with positive result of Human immunodeficiency virus (HIV)
- Female subject in lactation during the study period
- Subject with underlying medical, mental or psychological conditions that would impair the treatment compliance, or in the opinion of the Investigator would not permit to participate in the study
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
- Recruiting
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei
Shug-Cheng Chang, MD
- Not yet recruiting
Wanfang Hospital
Taipei
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.
Read the detailed description
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and 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
Subjects will be randomized to receive BB-101 or placebo, and expected 32 subjects for each arm.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Dosing Group | Active comparator | High Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks. Receives: Biological: BB-101 |
| Low Dose Dosing Group | Active comparator | Low Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks. Receives: Biological: BB-101 |
| Placebo Dosing Group | Placebo comparator | Placebo will be applied on the target lower leg or foot ulcer once a for 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.
Efficacy Evaluation
Percent change in wound surface area (cm^2) at each visit from baseline
Measured: 4 weeks
Secondary outcomes (2)
Secondary Efficacy Evaluation
Incidence of complete wound closure and change in Wagner Scale
Measured: 4 weeks
Safety Evaluation
To evaluate the Laboratory data, ECG examination results, physical examinations and vital signs changes from baseline, and AE incidences
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Blood Biotech Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shug-Cheng Chang, MD, Principal investigator, Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383013
- Sponsor's protocol ID
- BB-101-BBCBB1A
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2024
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
- ClinicalTrials.gov ID
- NCT06383013
- Acronym / sponsor ID
- BB-101-BBCBB1A
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Blue Blood Biotech Corp.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Apr 2024 (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-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.
Detailed description
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Dosing Group | Active comparator | Biological: BB-101High Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks. |
| Low Dose Dosing Group | Active comparator | Biological: BB-101Low Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks. |
| Placebo Dosing Group | Placebo comparator | Biological: BB-101Placebo will be applied on the target lower leg or foot ulcer once a for 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, at least 20 years of age (inclusive) at the date of Screening
- Subject or legally authorized representative who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
- Subject agrees to comply with ulcer care regimen for the duration of the study and is willing to return for all mandatory visits as defined in the protocol
- Subject with Type 1 or Type 2 diabetes mellitus (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) and is under the care of a physician for the management of diabetes mellitus
- Subject with glycosylated hemoglobin (HbA1c) ≤ 12%
Key exclusion criteria (30 listed)
- Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation.
- Local swelling or induration
- Erythema > 0.5 cm around wound
- Local tenderness or pain
- Local increased warmth
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-101Subjects will be randomized to receive BB-101 or placebo, and expected 32 subjects for each arm. | Biological | High Dose Dosing Group, Low Dose Dosing Group, Placebo Dosing Group |
Primary outcome
Efficacy Evaluation
Time frame: 4 weeks
Percent change in wound surface area (cm^2) at each visit from baseline
2 secondary outcomes
Secondary Efficacy Evaluation
Time frame: 4 weeks
Safety Evaluation
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Shug-Cheng Chang, MD principal investigator
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BB-101 in people with Diabetic Foot Ulcer, run by Blue Blood Biotech Corp. at 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassie Chuang (+886-2-87681220, cassie@ms.blueblood.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Evaluation (time frame: 4 weeks). 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 2 Oct 2026.