Actively Recruiting
Phase II Study to Evaluate the Efficacy and Safety of Topical 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a topical medication called BB-101 for treating diabetic foot and lower leg ulcers. This phase II clinical trial is randomized, double-blinded, vehicle-controlled, and parallel in design. The study includes adults with diabetes who have chronic ulcers that have not healed despite standard care, aiming to provide new treatment options for these persistent wounds. Participants will be randomly assigned to one of three groups: high dose BB-101, low dose BB-101, or a placebo. Each group will apply the assigned topical solution once daily to their target ulcer on the lower leg or foot for four consecutive weeks. All participants will continue to receive standard ulcer care throughout the study. The study is conducted at multiple locations and may expand to additional sites if needed. During the trial, participants will attend regular visits for assessments including measuring ulcer size and healing progress. Researchers will evaluate the efficacy of BB-101 after four weeks and monitor safety for six weeks. Participants will also undergo laboratory tests, physical exams, and other evaluations to ensure their health and track treatment effects. The total study duration and follow-up will cover these assessment periods to observe outcomes comprehensively.
CONDITIONS
Brief 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 and attend all study visits
- Diagnosed with type 1 or type 2 diabetes and under physician care
- Glycosylated hemoglobin (HbA1c) less than or equal to 12%
- Have at least one diabetic foot ulcer below the knees not healing for at least 4 weeks despite care
- Ulcer size between 0.5 cm² and 10 cm² confirmed by measurement
- Target ulcer graded 1 or 2 by Wagner Classification without infection signs
- Adequate blood circulation in affected limb as shown by specified tests
- Adequate liver and kidney function within specified laboratory limits
- Adequate blood cell counts and hemoglobin levels
- Negative pregnancy test for females within 28 days prior to treatment
- Use of effective contraception during treatment and for 4 weeks after if of childbearing potential
You will not qualify if you...
- Signs or symptoms of infection at the target ulcer
- Presence of cellulitis or gangrene at the ulcer site
- Active osteomyelitis requiring systemic antibiotics
- Significant ulcer size change (>30%) after 2 weeks of standard care before randomization
- Another open ulcer within 2 cm of target ulcer on same limb
- Ulcer caused by non-diabetic causes or related to unhealed amputation wound
- Structural deformities or conditions preventing off-loading of ulcer
- Use of certain medications or treatments (e.g., growth factors, systemic corticosteroids, immunosuppressants) before screening
- Participation in other clinical trials of investigational drugs or devices
- Recent use of skin grafts, dermal substitutes, or hyperbaric oxygen therapy
- Use of topical antimicrobials or enzymatic debridement within 7 days prior to screening
- History or current cancer except certain treated skin or cervical cancers
- Vasculitis, connective tissue diseases, or conditions impairing ulcer healing other than diabetes
- Diagnosis of sickle cell disease
- Significant ECG abnormalities
- Poor nutritional status (serum albumin < 2.5 g/dL)
- High C-reactive protein level (>50 mg/dL)
- History of drug or alcohol abuse
- Positive HIV test
- Lactating females during study period
- Medical, mental, or psychological conditions affecting compliance or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants apply BB-101 or placebo topical solution on the target lower leg or foot ulcer once a day for 4 consecutive weeks while continuing standard-of-care ulcer treatment.
Daily application with regular study visits
Duration - 2 weeks after treatment
Participants are monitored for safety and ulcer healing after treatment ends.
Visits during the 2-week post-treatment period
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
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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