Status:
UNKNOWN
Safety Study of Topical Human FGF-1 for Wound Healing
Lead Sponsor:
Phage Pharmaceuticals, Inc.
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
Detailed Description
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 chron...
Eligibility Criteria
Inclusion
- Sign an informed consent form prior to the initiation of any study procedures. Subjects must be competent to give written informed consent.
- Age must be between 18 to 75 years of age.
- 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.
- 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 In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed.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
- Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy.
- Subjects who, at study entry, are taking systemic antibiotics.
- Subjects who are immunosuppressed.
- Subjects experiencing bacterial or viral infection or who may otherwise be febrile.
- 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.
- Life expectancy of less than 1 year.
- Active alcohol or drug abuse within 6 months prior to study entry.
- Screening liver function tests of more than 2.0 times the upper limit of normal.
- Serum creatinine of ≥ 2.5 mg/dl.
- Hemoglobin A1c (HgbA1c) of \>10%.
- Exposure to any other investigational drugs or devices or participation in any other investigational studies within 30 days prior to study entry.
- 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).
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00916292
Start Date
November 1 2012
End Date
September 1 2013
Last Update
March 12 2012
Active Locations (1)
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1
Dedicated Phase I
Phoenix, Arizona, United States, 85013