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

NCT ID: NCT02119754

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot Ulcer Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plurogel PN

Plurogel PN

Group Type EXPERIMENTAL

Plurogel PN

Intervention Type DRUG

Interventions

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Plurogel PN

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkios BioDevelopment International

INDUSTRY

Sponsor Role collaborator

PluroGen Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ledesma Foot and Ankle

Phoenix, Arizona, United States

Site Status

Foot & Ankle Clinic

Los Angeles, California, United States

Site Status

Samuel Merritt University

Oakland, California, United States

Site Status

ASAP Urgent-Care

Hamden, Connecticut, United States

Site Status

Advance Medical Research Center

Miami, Florida, United States

Site Status

Miami Center for Clinical Research, LLC

Miami, Florida, United States

Site Status

Unlimited Medical Research, LLC

Miami, Florida, United States

Site Status

Phoenix Medical Research, LLC

Miami, Florida, United States

Site Status

Med Research of Florida, LCC

Miami, Florida, United States

Site Status

Sweet Hope Research Specialty, Inc.

Miami Lakes, Florida, United States

Site Status

Weil Foot & Ankle Institute

Des Plaines, Illinois, United States

Site Status

Research Integrity

Owensboro, Kentucky, United States

Site Status

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, United States

Site Status

AllCare Foot & Ankle, PA

Arlington, Texas, United States

Site Status

Coastal Podiatry Group

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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D11AC00020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PGN-1300X

Identifier Type: -

Identifier Source: org_study_id

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