NCT06383013

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

Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Blue Blood Biotech Corp. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-04-25
• Last updated: 2025-01-17

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study