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

NCT03888053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

BB-101

Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.

Sponsors & Collaborators

  • Blue Blood Biotech Corp.

    lead INDUSTRY

Principal Investigators

  • Shih-Chen Pan, MD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2021-12-01
Completion
2023-12-31
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 NCT03888053 on ClinicalTrials.gov