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NCT02119754 · ClinicalTrials.gov registry record · Phase 2
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
A Phase 2 study of Diabetic Foot Ulcer and Infection, sponsored by PluroGen Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 15
- Study locations
NCT02119754: Completed Phase 2 study of Diabetic Foot Ulcer and Infection, sponsored by PluroGen Therapeutics.
NCT02119754 is a Phase 2 study of Diabetic Foot Ulcer and Infection that has completed, run by PluroGen Therapeutics. The registered enrollment target is 15 participants, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (94% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02119754, a Phase 2 study of Diabetic Foot Ulcer and Infection, has completed, sponsored by PluroGen Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
Primary Outcome
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
Conditions Studied
Interventions
- DRUG Plurogel PN
Study Locations (15)
Florida
- Advance Medical Research Center - Miami
- Miami Center for Clinical Research, LLC - Miami
- Unlimited Medical Research, LLC - Miami
- Phoenix Medical Research, LLC - Miami
- Med Research of Florida, LCC - Miami
- Sweet Hope Research Specialty, Inc. - Miami Lakes
California
- Foot & Ankle Clinic - Los Angeles
- Samuel Merritt University - Oakland
Arizona
- Ledesma Foot and Ankle - Phoenix
Connecticut
- ASAP Urgent-Care - Hamden
Illinois
- Weil Foot & Ankle Institute - Des Plaines
Kentucky
- Research Integrity - Owensboro
Pennsylvania
- Paddington Testing Company, Inc - Philadelphia
Texas
- AllCare Foot & Ankle, PA - Arlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT02119754 record still lists
NCT02119754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Plurogel PN is the first listed.
NCT02119754 lists 15 locations in 9 states (Florida, California, Arizona).
Frequently Asked Questions
What is clinical trial NCT02119754 about?
NCT02119754 is a clinical study titled "Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers". This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have fai...
What is the current status of trial NCT02119754?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2013-10. Estimated completion is 2014-09.
What conditions does trial NCT02119754 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Infection.
What interventions are being tested in trial NCT02119754?
The interventions under investigation include: Plurogel PN (DRUG).
Who is sponsoring clinical trial NCT02119754?
This trial is sponsored by PluroGen Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02119754 being conducted?
This trial has 15 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02119754's enrollment target sits among peer trials
15 64th of 67 higher than 3 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer 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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