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NCT02119754 Clinical Trial

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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02119754
Other study ID # PGN-1300X
Secondary ID D11AC00020
Status Completed
Phase Phase 2
First received April 17, 2014
Last updated September 24, 2014
Start date October 2013
Est. completion date September 2014

Study information
Verified date September 2014
Source PluroGen Therapeutics, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Plurogel PN

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

Sponsors (2)
Lead Sponsor Collaborator
PluroGen Therapeutics, Inc Arkios BioDevelopment International

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Response Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection. 14 days No
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