Actively Recruiting
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
Led by Blue Blood Biotech Corp. · Updated on 2026-04-22
96
Participants Needed
5
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, at least 20 years of age at screening
- Able to understand the study and provide written informed consent
- Willing to follow ulcer care regimen and attend all study visits
- Diagnosed with Type 1 or Type 2 diabetes and under physician care
- Glycosylated hemoglobin (HbA1c) of 12% or less
- At least one diabetic foot ulcer located below the knee that has not healed for 4 weeks or more
- Target ulcer size between 0.5 cm² and 10 cm² confirmed at screening and randomization visits
- Target ulcer classified as Grade 1 or 2 by Wagner Classification, without signs of infection
- Adequate blood flow to affected limb shown by specific oxygen or pressure tests
- Adequate liver function (ALT and AST ≤ 2 times upper limit of normal) and kidney function (serum creatinine ≤ 3 mg/dL)
- Adequate blood counts: ANC ≥ 1,500 cells/µL, WBC ≥ 3,000 cells/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 10 g/dL for males or ≥ 9 g/dL for females
- Negative pregnancy test for females within 28 days before treatment
- Use of appropriate contraception during treatment and for 4 weeks after stopping for males and females of childbearing potential
You will not qualify if you...
- Signs or symptoms of infection in the target ulcer, including swelling, redness over 0.5 cm, tenderness, warmth, or pus
- Cellulitis or gangrene in the lower leg or foot with the target ulcer
- Active bone infection (osteomyelitis) requiring antibiotics within 1 week before screening
- Ulcer size changed by 30% or more after 2 weeks of standard care before randomization
- Another open ulcer less than 2 cm from the target ulcer on the same leg or foot
- Ulcer caused mainly by conditions other than diabetes
- Ulcers related to incompletely healed amputation wounds
- Structural deformities or conditions preventing proper off-loading of ulcer
- Use of certain medications or treatments within specified timeframes including growth factors, systemic corticosteroids, immunosuppressants, radiation, chemotherapy, skin grafts, hyperbaric oxygen, topical antimicrobials, or enzymatic debridement
- History or current cancer except certain treated skin or cervical cancers without recurrence
- Vasculitis, connective tissue diseases, or other conditions impairing ulcer healing besides diabetes
- Sickle cell disease
- Significant abnormal electrocardiogram findings
- Poor nutrition (serum albumin < 2.5 g/dL)
- High C-reactive protein (> 50 mg/dL)
- History of drug or alcohol abuse per DSM-5
- Positive HIV test
- Lactating females during the study
- Medical, mental, or psychological conditions interfering with study compliance or participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
2
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Actively Recruiting
3
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei, Taiwan
Actively Recruiting
4
Wanfang Hospital
Taipei, Taiwan
Not Yet Recruiting
5
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Actively Recruiting
Research Team
C
Cassie Chuang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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