Olivamine-containing Products in the Management of Patients With Nonhealing Lower Extremity Ulcers

Inclusion Criteria:

• Patient is 18 years old or older.
• Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound.
• Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone.
• Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult.
• Study ulcer/wound has been present for greater than 6 weeks prior to initial consult.
• Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device.
• The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg.
• Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen.
• Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening.

Exclusion Criteria:

• An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study.
• Patient has clinical evidence of gangrene or infection on any part of the affected foot.
• The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits.
• Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis).
• Patient has muscle, tendon, or bone exposure in any ulcer bed.
• Patient has known sensitivity or allergy to any component of the study product - Olivamine10.
• Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the - Investigator would make the patient an inappropriate candidate for this wound healing study.
• Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more.
• Patient has known alcohol or drug abuse.
• Patient has a hematocrit greater than 60% or less than 27%.
• Patient's diabetes is under poor control as manifested by HbA1c of >10.0%.
• Patient has clinically significant renal insufficiency or creatinine greater than 2.0 mg/dL.
• Patient has chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT, or bilirubin greater than 1.5 times upper limit of normal (ULN).
• Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
• Patient is using tobacco, or is exposed to a current smoker in their household. Patients may participate in the study if they have not used tobacco for 3 months and have not had a smoker in their household for 3 months.
• Patient is using any form of nicotine including nicotine patches, gums, or sprays.
• Patient has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV).