Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

Exclusion Criteria

• •1. Has a known hypersensitivity to any of the study medication components.
• •2. Exposure to any investigational product within 30 days of entry into study.
• •3. Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years.
• •4. Chronic liver dysfunction evidenced by transaminase levels \> 2.5 times higher than the upper level of normal on two occasions.
• •5. Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G)
• •6. Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
• •7. Prior radiation therapy of the foot with the ulcer under study.
• •8. Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study
• •9. Sickle-cell anemia, Raynaud's or other peripheral vascular disease.
• •10. Subjects receiving a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the 7 days prior to exposure to DSC127.
• •11. Subject who, in the opinion of the investigator, has uncontrolled hypertension
• •12. Subject has an ulcer which is determined to be clinically infected and requires antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7 days for any reason. (Subjects with infection at the initial visit of the Screening Period can be re-screened three weeks later after a single course of antibiotic therapy (occurring concurrently - within three weeks of the initial visit, the antibiotic treatment must have completed and some washout (7 days) must have elapsed); if after that time infection is still present, the subject will be excluded.)
• •13. Subjects who, in the opinion of the investigator, have clinically significant anemia