Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
2 other identifiers
interventional
15
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2013
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
11 months
April 17, 2014
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Response
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
14 days
Study Arms (1)
Plurogel PN
EXPERIMENTALPlurogel PN
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who have failed treatment on Protocol PGN-1300X
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PluroGen Therapeutics, Inclead
- Arkios BioDevelopment Internationalcollaborator
Study Sites (15)
Ledesma Foot and Ankle
Phoenix, Arizona, 85032, United States
Foot & Ankle Clinic
Los Angeles, California, 90010, United States
Samuel Merritt University
Oakland, California, 94609, United States
ASAP Urgent-Care
Hamden, Connecticut, 06514, United States
Advance Medical Research Center
Miami, Florida, 33135, United States
Miami Center for Clinical Research, LLC
Miami, Florida, 33144, United States
Unlimited Medical Research, LLC
Miami, Florida, 33144, United States
Phoenix Medical Research, LLC
Miami, Florida, 33165, United States
Med Research of Florida, LCC
Miami, Florida, 33186, United States
Sweet Hope Research Specialty, Inc.
Miami Lakes, Florida, 33016, United States
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
Research Integrity
Owensboro, Kentucky, 42303, United States
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103, United States
AllCare Foot & Ankle, PA
Arlington, Texas, 76015, United States
Coastal Podiatry Group
Virginia Beach, Virginia, 23464, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 22, 2014
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09