Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189638
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-06
Brief Title:
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
Sponsor:
Jiangsu ProteLight Pharmaceutical Biotechnology Co Ltd
Organization:
Jiangsu ProteLight Pharmaceutical Biotechnology Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
PL-5
Brief Summary:
This is a Phase II randomized double-blind placebo-controlled multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers Eligible subjects will be randomized 111 to receive twice a day 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray 1 Antimicrobial Peptide PL-5 Topical Spray 2 and topical placebo vehicle spray In this study the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study
Detailed Description:
This is a Phase II randomized double-blind placebo-controlled multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers Approximately 90 patients 30 per treatment group will be randomized in this study Eligible subjects will be randomized 111 to receive twice a day 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray 1 Antimicrobial Peptide PL-5 Topical Spray 2 and placebo of Antimicrobial Peptide PL-5 Topical Spray vehicle In this study the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study The duration of the whole study is planned for 24 months the duration of each participant is about 4-5 weeks including Screening periodBaseline about 7 days treatment period about 14 days Follow-up period about 7-14 days No interim analysis will be performed in this study This study is a phase II study and no statistical hypothesis is proposed
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