BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

NCT06383013 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BB-101-BBCBB1A
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Efficacy Evaluation

  Percent change in wound surface area (cm\^2) at each visit from baseline

  4 weeks

Secondary Outcomes (2)

• Secondary Efficacy Evaluation

  4 weeks

• Safety Evaluation

  6 weeks

Other Outcomes (2)

• Exploratory Objectives

  6 weeks

• Exploratory Objectives

  6 weeks

Study Arms (3)

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.

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.

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.

Biological: BB-101

Interventions

BB-101 BIOLOGICAL

Subjects will be randomized to receive BB-101 or placebo, and expected 32 subjects for each arm.

High Dose Dosing Group; Low Dose Dosing Group; Placebo Dosing Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Visit:
• i. 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:
• i. 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.

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Blue Blood Biotech Corp.: lead

Study Sites (5)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Taipei, Taiwan

RECRUITING

Wanfang Hospital

Taipei, Taiwan

NOT YET RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Shug-Cheng Chang, MD

  Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassie Chuang

CONTACT

+886-2-87681220; cassie@ms.blueblood.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2025-05

Locations

TW (5)