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

PluroGen Therapeutics

Status and phase: Completed; Phase 2

Conditions: Infection; Diabetic Foot Ulcer

Treatments: Drug: Plurogel PN

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119754

D11AC00020 (Other Grant/Funding Number)

PGN-1300X

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Plurogel PN

Experimental group

Description:

Plurogel PN

Treatment:

Drug: Plurogel PN