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

All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until
complete wound closure (defined as skin re-epithelialization without drainage or dressing
requirement) or 24 weeks, whichever occurs first.

If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24
weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period
of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer
develops that meets study criteria.

For the entire duration of each treatment period the standard of care for DFU will be
maintained.

Inclusion Criteria:

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

2. Have at least one ulcer:

1. chronic ( present >1month)

2. Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and not
involving bone, tendon or capsule (probing to tendon or capsule) and/or
penetrating to tendon or capsule.)

3. with no sign of infection or osteomyelitis, and

4. is located below the malleolus.

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

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

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

6. Female subjects of child-bearing potential must be willing to use a medically
acceptable method of birth control, such as Essure®, hormonal contraception (oral
pills, implantable device or skin patch), intrauterine device, tubal ligation, double
barrier, or abstinence during the treatment periods of study participation.

7. Ability and willingness to understand and comply with study procedures and to give
written informed consent prior to enrollment in the study or initiation of study
procedures

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