Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
NCT02119754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2014-09-25
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.
Conditions
- Diabetic Foot Ulcer
- Infection
Interventions
- DRUG
-
Plurogel PN
Sponsors & Collaborators
-
Arkios BioDevelopment International
collaborator INDUSTRY -
PluroGen Therapeutics, Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-10-31
- Primary Completion
- 2014-09-30
- Completion
- 2014-09-30
Countries
- United States
Study Locations
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