- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916292
Safety Study of Topical Human FGF-1 for Wound Healing
March 9, 2012 updated by: Phage Pharmaceuticals, Inc.
A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85013
- Dedicated Phase I
-
Contact:
- Shawn Searle, MD
- Phone Number: 602-279-7300
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose
Four subjects will receive low dose FGF-1
|
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control.
Low dose: FGF-1, 0.3 mg per square centimeter.
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control.
High dose: FGF-1, 3.0 mg per square centimeter.
|
Experimental: High Dose
Four subjects will receive high dose FGF-1
|
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control.
Low dose: FGF-1, 0.3 mg per square centimeter.
Each subject will receive two, 3 mm squared punch skin biopsies, one biopsy will receive the study drug, and the second biopsy will remain untreated as a control.
High dose: FGF-1, 3.0 mg per square centimeter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum levels of FGF-1 after topical administration
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shawn Searle, MD, Dedicated Phase I
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
June 5, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 9, 2009
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 9, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Phage-W2009-01-1a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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