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

Inclusion Criteria: * Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic criteria (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered "controlled" by diet or medication in the opinion of the physician. * Males or females at least 18 years old. * Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form. * Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area ≥1 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA criteria as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis. IDSA mild infection of an ulcer is defined as: The presence of ≥2 of the following items: * Local swelling or induration * Erythema * Local tenderness or pain * Local warmth * Purulent discharge (thick, opaque to white or sanguineous secretion) Local infection involving only the skin and the subcutaneous tissue. If erythema, must be \>0.5 cm to ≤2 cm around the ulcer. * Diabetic Foot Infection-General Parameters Score of at least 2 mus…