Back to resultsSafety Study of Topical Human FGF-1 for Wound Healing
Primary Purpose
Diabetic Foot Ulcers
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FGF-1 141
FGF-1 141
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetes, dermal ulcers
Eligibility Criteria
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 In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed.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).
Sites / Locations
- Dedicated Phase I
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose
High Dose
Arm Description
Four subjects will receive low dose FGF-1
Four subjects will receive high dose FGF-1
Outcomes
Primary Outcome Measures
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
Secondary Outcome Measures
Serum levels of FGF-1 after topical administration
Full Information
NCT ID
NCT00916292
First Posted
June 5, 2009
Last Updated
March 9, 2012
Sponsor
Phage Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00916292
Brief Title
Safety Study of Topical Human FGF-1 for Wound Healing
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phage Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetes, dermal ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Four subjects will receive low dose FGF-1
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Four subjects will receive high dose FGF-1
Intervention Type
Drug
Intervention Name(s)
FGF-1 141
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FGF-1 141
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability of a single dose of FGF-1 topically administered in normal volunteers given an artificial dermal wound
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Serum levels of FGF-1 after topical administration
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn Searle, MD
Organizational Affiliation
Dedicated Phase I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dedicated Phase I
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Searle, MD
Phone
602-279-7300
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Topical Human FGF-1 for Wound Healing
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