NCT03888053

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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Topical BB-101 (rhNEGF) for the Treatment of Diabetic Lower Leg and Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Blue Blood Biotech Corp. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study will be conducted at multiple investigational sites located in Taiwan. Additional sites and countries may be added during the course of the study if required.

Conditions

• Diabetic Foot Ulcer

Interventions

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

Timeline

• Start date: 2018-03-28
• Primary completion: 2021-12-01
• Completion: 2023-12-31
• First posted: 2019-03-25
• Last updated: 2024-04-23

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study