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

• Sponsor: PluroGen Therapeutics, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02119754
• Collaborator: Arkios BioDevelopment International (Industry)
• Enrollment: 15
• Locations: 15
• Arm: 1
• Duration (Months): 11
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer; Infection	Drug: Plurogel PN	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical Response [14 days]

   Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ledesma Foot and Ankle	Phoenix	Arizona	United States	85032
2	Foot & Ankle Clinic	Los Angeles	California	United States	90010
3	Samuel Merritt University	Oakland	California	United States	94609
4	ASAP Urgent-Care	Hamden	Connecticut	United States	06514
5	Sweet Hope Research Specialty, Inc.	Miami Lakes	Florida	United States	33016
6	Advance Medical Research Center	Miami	Florida	United States	33135
7	Miami Center for Clinical Research, LLC	Miami	Florida	United States	33144
8	Unlimited Medical Research, LLC	Miami	Florida	United States	33144
9	Phoenix Medical Research, LLC	Miami	Florida	United States	33165
10	Med Research of Florida, LCC	Miami	Florida	United States	33186
11	Weil Foot & Ankle Institute	Des Plaines	Illinois	United States	60016
12	Research Integrity	Owensboro	Kentucky	United States	42303
13	Paddington Testing Company, Inc	Philadelphia	Pennsylvania	United States	19103
14	AllCare Foot & Ankle, PA	Arlington	Texas	United States	76015
15	Coastal Podiatry Group	Virginia Beach	Virginia	United States	23464

Sponsors and Collaborators

• PluroGen Therapeutics, Inc
• Arkios BioDevelopment International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PluroGen Therapeutics, Inc
• ClinicalTrials.gov Identifier: NCT02119754
• Other Study ID Numbers: PGN-1300X; D11AC00020
• First Posted: Apr 22, 2014
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by PluroGen Therapeutics, Inc: Wound; Ulcer; Infected; Infection
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer

Study Results

No Results Posted as of Sep 25, 2014