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

September 24, 2014 updated by: PluroGen Therapeutics, Inc

Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Ledesma Foot and Ankle
    • California
      • Los Angeles, California, United States, 90010
        • Foot & Ankle Clinic
      • Oakland, California, United States, 94609
        • Samuel Merritt University
    • Connecticut
      • Hamden, Connecticut, United States, 06514
        • ASAP Urgent-Care
    • Florida
      • Miami, Florida, United States, 33135
        • Advance Medical Research Center
      • Miami, Florida, United States, 33144
        • Unlimited Medical Research, LLC
      • Miami, Florida, United States, 33165
        • Phoenix Medical Research, LLC
      • Miami, Florida, United States, 33144
        • Miami Center for Clinical Research, LLC
      • Miami, Florida, United States, 33186
        • Med Research of Florida, LCC
      • Miami Lakes, Florida, United States, 33016
        • Sweet Hope Research Specialty, Inc.
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Weil Foot & Ankle Institute
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Company, Inc
    • Texas
      • Arlington, Texas, United States, 76015
        • AllCare Foot & Ankle, PA
    • Virginia
      • Virginia Beach, Virginia, United States, 23464
        • Coastal Podiatry Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plurogel PN
Drug: Plurogel PN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response
Time Frame: 14 days
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PluroGen Therapeutics, Inc

Collaborators

Arkios BioDevelopment International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGN-1300X
  • D11AC00020 (Other Grant/Funding Number: DoD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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