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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02119754

Enrollment

Registered

2014-04-22

Start date

2013-10-31

Completion date

2014-09-30

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer, Infection

Keywords

Wound, Ulcer, Infected, Infection

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.

Interventions

DRUGPlurogel PN

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026