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

NCT06383013 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

BB-101

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

Sponsors & Collaborators

  • Blue Blood Biotech Corp.

    lead INDUSTRY

Principal Investigators

  • Shug-Cheng Chang, MD · Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06383013 on ClinicalTrials.gov