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

Inclusion Criteria:

1. Male or female ambulatory subjects who are at least 18 years of age at screening

2. Have at least one ulcer:

3. chronic ( present >1month)

4. Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and notinvolving bone, tendon or capsule (probing to tendon or capsule) and/orpenetrating to tendon or capsule.)

5. with no sign of infection or osteomyelitis, and

6. is located below the malleolus.

7. Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHgto ensure healing potential.

8. Have Type I or Type II diabetes under metabolic control as confirmed by glycosylatedhemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to studyenrollment.

9. Female subjects of child-bearing potential must have a negative pregnancy test at thetime of enrollment and at the initiation of each study treatment period.

10. Female subjects of child-bearing potential must be willing to use a medicallyacceptable method of birth control, such as Essure®, hormonal contraception (oralpills, implantable device or skin patch), intrauterine device, tubal ligation, doublebarrier, or abstinence during the treatment periods of study participation.

11. Ability and willingness to understand and comply with study procedures and to givewritten informed consent prior to enrollment in the study or initiation of studyprocedures

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 currentlydisease-free, may be considered for study entry. Disease-free is defined as inremission for at least 5 years.

4. Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than theupper 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 prolongQT/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 toenrollment 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 requiresantimicrobials or agents known to affect wound healing or has been taking systemicantibiotics for more than 7 days for any reason. (Subjects with infection at theinitial visit of the Screening Period can be re-screened three weeks later after asingle course of antibiotic therapy (occurring concurrently - within three weeks ofthe initial visit, the antibiotic treatment must have completed and some washout (7days) must have elapsed); if after that time infection is still present, the subjectwill be excluded.)

13. Subjects who, in the opinion of the investigator, have clinically significant anemia