Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383013
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
Sponsor:
Blue Blood Biotech Corp
Organization:
Blue Blood Biotech Corp
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None