Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers

Exclusion Criteria

• •Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
• •Chronic renal insufficiency and/or chronic liver dysfunction
• •Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
• •Malignancy of any kind
• •Receiving hemodialysis or CAPD
• •Current history of drug abuse, and/or known to be HIV positive
• •Prior radiation therapy of the foot under study
• •Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days
• •Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason
• •Sickle-cell anemia, Raynaud's or other peripheral vascular disease
• •Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis
• •An EKG with a marked baseline prolongation of QT/QTc interval