Peripheral Angiogenesis Research: Aventis FGF-2 Trial
Study of:
Angiogenic growth factor FGF-2
We are currently studying the angiogenic growth factor FGF-2 in patients with severe PAD. In this study, patients are randomized to receive the gene for FGF-2 or placebo in a 5:1 ratio. (Choose the following link for more on gene therapy. FGF-2 is a growth factor being studied for it’s ability to “create” or increase the blood supply to specific areas of the body in need of more blood. By giving more of what your body produces naturally, that is, growth factors, new blood vessels may grow which may possibly improve the blood supply to your legs and feet to promote wound healing and decrease pain.
Entry Criteria:
Inclusion
- Age greater than 45 years old
- Severe peripheral arterial disease (PAD) with rest pain and non-healing ulcers
- Objective evidence of peripheral arterial disease such as a diminished pulse in an extremity
- A leg angiogram that shows a totally blocked blood vessel
- No option for surgery
Exclusion
- Current history of cancer
- Bypass or angioplasty of the limb with PAD within the past 3 months
- Elevated creatinine (measure of kidney function)
- Buerger’s disease
- Retinopathy
- Stroke within 3 months
Study Requirements:
- Screening Process (~ 4-8 weeks)
- Drug Administration: 6 groups = 5 groups get gene therapy drug (2000-16000?g) + 1 placebo group
- 4 treatments administered over 6 weeks (injections into muscle)
- Follow-up visits continuing for 1 year, annual check ups with your physician for 15 years
- JoAnne Goldman, RTR, RCIS, CCRC
For more information about the peripheral vascular research program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact JoAnne Goldman at 612-863-3793.
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