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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: Active Phase 2 study of Diabetic Foot Ulcers, sponsored by Jiangsu ProteLight Pharmaceutical & Biotechnology Co..
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
the Investigator will grade the clinical response as （1）"infection resolved or cured" (all signs and symptoms of infection resolved);（2）"infection improving"(most, but not all, signs and symptoms of infection improved or resolved)（3）"treatment failure" (≥1 signs or symptoms of infection substantially worsening), (4)"unevaluable"(\<3 days of study treatment or patient lost to follow-up), or （5）"recurrence"(a previously cured or improved infection showing worsening of signs or symptoms of infectio
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 |
What the registry record for NCT06189638 still lists
NCT06189638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 227-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (60% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06189638's enrollment target sits among peer trials
90 8th of 12 higher than 5 of 12 other Diabetic Foot Ulcers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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