Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

Completed · Phase 2

Conditions studied: Diabetic Foot Ulcer, Infection

In brief

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.

Key facts

Study ID

NCT02119754

Run by

PluroGen Therapeutics, Inc

People needed

15

Starts

2013-10-01

Expected to finish

2014-09-01

Last updated by the study team

2014-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have failed treatment on Protocol PGN-1300X

Where it is running

• Ledesma Foot and Ankle — Phoenix, Arizona, United States
• Foot & Ankle Clinic — Los Angeles, California, United States
• Samuel Merritt University — Oakland, California, United States
• ASAP Urgent-Care — Hamden, Connecticut, United States
• Advance Medical Research Center — Miami, Florida, United States
• Miami Center for Clinical Research, LLC — Miami, Florida, United States
• Unlimited Medical Research, LLC — Miami, Florida, United States
• Phoenix Medical Research, LLC — Miami, Florida, United States
• Med Research of Florida, LCC — Miami, Florida, United States
• Sweet Hope Research Specialty, Inc. — Miami Lakes, Florida, United States
• Weil Foot & Ankle Institute — Des Plaines, Illinois, United States
• Research Integrity — Owensboro, Kentucky, United States
• Paddington Testing Company, Inc — Philadelphia, Pennsylvania, United States
• AllCare Foot & Ankle, PA — Arlington, Texas, United States
• Coastal Podiatry Group — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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