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NCT06189638 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
A Phase 2 study of Diabetic Foot Ulcers, sponsored by Jiangsu ProteLight Pharmaceutical & Biotechnology Co..
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 3
- Study locations
NCT06189638 is a Phase 2 study of Diabetic Foot Ulcers that is active but no longer recruiting, run by Jiangsu ProteLight Pharmaceutical & Biotechnology Co.. The registered enrollment target is 90 participants, below the 227-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (60% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT06189638, a Phase 2 study of Diabetic Foot Ulcers, is active but no longer recruiting, sponsored by Jiangsu ProteLight Pharmaceutical & Biotechnology Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 3
- Study locations
Study 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 (1:1:1) 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
Conditions Studied
Interventions
- DRUG Antimicrobial Peptide PL-5 Topical Spray and Placebo
Study Locations (3)
Florida
- Bioresearch Partner Holdings, LLLP - Miami
- Santos Research Center, Corp - Tampa
California
- ILD Research Center - Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-01-30 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06189638
The ClinicalTrials.gov registry entry for NCT06189638 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (60% lower). The listed sponsor is Jiangsu ProteLight Pharmaceutical & Biotechnology Co., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcers appearing as the primary indexed condition, and to 1 intervention - of which Antimicrobial Peptide PL-5 Topical Spray and Placebo is the first listed.
NCT06189638 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, California.
Frequently Asked Questions
What is clinical trial NCT06189638 about?
NCT06189638 is a clinical study titled "Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers". 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 (1:1:1) to receive twice a day,...
What is the current status of trial NCT06189638?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-01-30. Estimated completion is 2027-12-30.
What conditions does trial NCT06189638 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcers.
What interventions are being tested in trial NCT06189638?
The interventions under investigation include: Antimicrobial Peptide PL-5 Topical Spray and Placebo (DRUG).
Who is sponsoring clinical trial NCT06189638?
This trial is sponsored by Jiangsu ProteLight Pharmaceutical & Biotechnology Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06189638 being conducted?
This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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