A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

Exclusion Criteria

• •1. History of anaphylaxis, known hypersensitivity to sodium alginate, propylene glycol, methylene-blue or chicken-egg
• •2. Target ulcer is over a deformity (such as Charcot deformity) that interferes with off-loading based on investigator's opinion
• •3. Index wound duration of \> 3 years without intermittent healing
• •4. Clinical evidence of ulcer bed infection or patients requiring intravenous (IV) antibiotics to treat the index wound infection at time of randomization
• •5. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site, or documented history of osteomyelitis at the target wound location during the 8 weeks preceding the screening visit
• •6. Major uncontrolled medical disorder(s) such as severe uncontrolled leg edema, concurrent medication, or other issue that renders the patient unsuitable for participation in the study, including but not limited to: comorbid condition with an estimated life expectancy of ≤ 12 months, hemoglobin A1c (Hba1c) \> 12 % at screening, patients on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA IV, uncontrolled hypertension systolic BP by repeated measurement \> 180 mmHg)
• •7. Raynaud disease or any other severe peripheral microvascular disease, current diagnosis of vasculitis
• •7a. Patients with PAD who
• •have not been assessed by vascular imaging as per standard of care or
• •have acute peripheral artery occlusion of the index extremity or
• •have PAD Fontaine Stage III and IV or
• •have PAD with planned revascularization during the upcoming 6 months or
• •had Angioplasty for re-perfusion in the lower extremity with target ulcer during 3 months preceding the screening visit
• •8\. Dermatologic comorbid disease (e.g. pyoderma gangrenosum, vasculopathy or vasculitic ulcers), history of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans)
• •9\. Patient currently treated for an active malignant disease or prior diagnosis of an active malignant disease who is disease free for less than 1 year. Treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy or gene therapy) within 3 months before the first administration of investigational product or at any time during the study.
• •10\. Patient with history of malignancy within the wound; history of radiation therapy to the wound region
• •11\. Patients who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days or during the study
• •12\. Patients who received oral or parenteral corticosteroids, immunosuppressants, or cytotoxic agents within 30 days preceding the first study drug administration, or plan to use these medications during the study period
• •13\. Patients who are pregnant or breastfeeding
• •14\. Mental condition rendering the patient (or the patient's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study
• •15\. Patients who are incarcerated, including prisoners or patients compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
• •16\. Therapy with another investigational agent within thirty days of screening, or during the study
• •17\. Patients who are considered by the investigator to have a significant disease, which can impact the study; patients who are considered not suitable for the study by the investigator
• •18\. Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor