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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02119754
The ClinicalTrials.gov registry entry for NCT02119754 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (94% lower). The listed sponsor is PluroGen Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 15 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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