Safety Study of Topical Human FGF-1 for Wound Healing

Dermal ulcers pose a significant healthcare problem in the United States, ultimately
affecting 10-15% of the approximately 20 million patients with diabetes and a similar number
of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from
compromised arterial inflow, microvascular perfusion or venous outflow which can lead to
amputation unless vascular perfusion is improved. FGF-1 for topical administration offers
the possibility of improved microvascular perfusion by promoting the formation of new blood
vessels in the wound bed resulting in enhanced development of granulation tissue and
accelerated healing.

Inclusion Criteria:

1. Sign an informed consent form prior to the initiation of any study procedures.
Subjects must be competent to give written informed consent.

2. Age must be between 18 to 75 years of age.

3. Female subject must be post-menopausal or sterilized, or if she is of childbearing
potential, she is not breast feeding, and her serum pregnancy test is negative.

4. Subjects must be willing to change their wound dressings daily and demonstrate to
study personnel the ability to follow the dressing care instructions indicated in the
Appendix. Subjects considered eligible to enter the study must sign an informed
consent form prior to the initiation of any study procedures. In the event that the
subject must be withdrawn and is re-screened for study participation at a later date,
a new informed consent form must be signed. Subjects must be competent to give
written informed consent.

Exclusion Criteria:

1. Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or
chemotherapy.

2. Subjects who, at study entry, are taking systemic antibiotics.

3. Subjects who are immunosuppressed.

4. Subjects experiencing bacterial or viral infection or who may otherwise be febrile.

5. Past history or current presence of any type of cancer (except past history of basal
cell carcinoma that is not on the limb being treated). Subjects with existing BCC
will be excluded from the study.

6. Life expectancy of less than 1 year.

7. Active alcohol or drug abuse within 6 months prior to study entry.

8. Screening liver function tests of more than 2.0 times the upper limit of normal.

9. Serum creatinine of ≥ 2.5 mg/dl.

10. Hemoglobin A1c (HgbA1c) of >10%.

11. Exposure to any other investigational drugs or devices or participation in any other
investigational studies within 30 days prior to study entry.

12. Any other medical, social, or geographical factor that would make it unlikely that
the subject will comply with study procedures (e.g., alcohol abuse, lack of permanent
residence, severe depression, disorientation, distant location, or a history of
non-compliance).