Clinical Trials List
2023-07-01 - 2027-12-31
Phase II
Recruiting5
ICD-10L97.901
Non-pressure chronic ulcer of unspecified part of unspecified lower leg limited to breakdown of skin
ICD-10L97.902
Non-pressure chronic ulcer of unspecified part of unspecified lower leg with fat layer exposed
ICD-10L97.903
Non-pressure chronic ulcer of unspecified part of unspecified lower leg with necrosis of muscle
ICD-10L97.904
Non-pressure chronic ulcer of unspecified part of unspecified lower leg with necrosis of bone
ICD-10L97.909
Non-pressure chronic ulcer of unspecified part of unspecified lower leg with unspecified severity
ICD-10L97.911
Non-pressure chronic ulcer of unspecified part of right lower leg limited to breakdown of skin
ICD-10L97.912
Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed
ICD-10L97.913
Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle
ICD-10L97.914
Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone
ICD-10L97.919
Non-pressure chronic ulcer of unspecified part of right lower leg with unspecified severity
ICD-10L97.921
Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin
ICD-10L97.922
Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed
ICD-10L97.923
Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle
ICD-10L97.924
Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone
ICD-10L97.929
Non-pressure chronic ulcer of unspecified part of left lower leg with unspecified severity
ICD-9707.10
Ulcer of lower limb, unspecified
A Randomized, Double-Blinded, Vehicle-Controlled, Parallel, Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 (rhNEGF) for the Treatment of Diabetic Lower Leg and Foot Ulcers
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Sponsor
Blue Blood Biotech Corporation
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 洪國書 Division of Plastic Surgery
- Tak-Wah Wong Division of Dermatology
- 薛元毓 Division of Plastic Surgery
- Horng-Yih Ou Division of Endocrinology
- 張子彥 Division of Plastic Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 洪士淵 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
) at each visit from baseline.
Inclution Criteria
2. 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
3. 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
4. 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
5. Subject with glycosylated hemoglobin (HbA1c) ≤ 12%
Exclusion Criteria
3. Subject with active osteomyelitis, which requires systemic antibiotics. Systemic
antibiotics must be complete or discontinued 1 week prior to Screening Visit.
4. 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
5. Subject with another open ulcer < 2 cm away from target ulcer, on the same lower
leg or foot
6. Subject with target ulcer caused primarily by etiologies not related to diabetes
7. Subject with target ulcers related to an incompletely healed amputation wound
8. 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
The Estimated Number of Participants
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Taiwan
106 participants
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Global
106 participants
