Back to resultsTopical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcer, Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plurogel PN
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Wound, Ulcer, Infected, Infection
Eligibility Criteria
Inclusion Criteria:
- Subjects who have failed treatment on Protocol PGN-1300X
Exclusion Criteria:
-
Sites / Locations
- Ledesma Foot and Ankle
- Foot & Ankle Clinic
- Samuel Merritt University
- ASAP Urgent-Care
- Sweet Hope Research Specialty, Inc.
- Advance Medical Research Center
- Miami Center for Clinical Research, LLC
- Unlimited Medical Research, LLC
- Phoenix Medical Research, LLC
- Med Research of Florida, LCC
- Weil Foot & Ankle Institute
- Research Integrity
- Paddington Testing Company, Inc
- AllCare Foot & Ankle, PA
- Coastal Podiatry Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plurogel PN
Arm Description
Plurogel PN
Outcomes
Primary Outcome Measures
Clinical Response
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
Secondary Outcome Measures
Full Information
NCT ID
NCT02119754
First Posted
April 17, 2014
Last Updated
September 24, 2014
Sponsor
PluroGen Therapeutics, Inc
Collaborators
Arkios BioDevelopment International
1. Study Identification
Unique Protocol Identification Number
NCT02119754
Brief Title
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
Official Title
Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PluroGen Therapeutics, Inc
Collaborators
Arkios BioDevelopment International
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Infection
Keywords
Wound, Ulcer, Infected, Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plurogel PN
Arm Type
Experimental
Arm Description
Plurogel PN
Intervention Type
Drug
Intervention Name(s)
Plurogel PN
Primary Outcome Measure Information:
Title
Clinical Response
Description
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have failed treatment on Protocol PGN-1300X
Exclusion Criteria:
-
Facility Information:
Facility Name
Ledesma Foot and Ankle
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Foot & Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
Samuel Merritt University
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
ASAP Urgent-Care
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06514
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Advance Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Miami Center for Clinical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Unlimited Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Phoenix Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Med Research of Florida, LCC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Weil Foot & Ankle Institute
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Research Integrity
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Paddington Testing Company, Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
AllCare Foot & Ankle, PA
City
Arlington
State/Province
Texas
ZIP/Postal Code
76015
Country
United States
Facility Name
Coastal Podiatry Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23464
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
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