Abstract
The objective of the HGF-STAT clinical trial is to determine whether perfusion can be improved by gene transfer with a plasmid DNA containing hepatocyte growth factor (HGF) in the affected limb of patients with unreconstructable critical limb ischemia (CLI). CLI results in a high rate of limb loss and impaired quality of life. The current therapeutic strategies, including bypass surgery and percutaneous interventions, are only successful in treating a subset of patients. Therapeutic angiogenesis is an investigational method that seeks to favorably impact tissue perfusion in CLI. HGF-STAT is a double-blind, parallel-group, placebo-controlled, dose - response Rudy in 100 patients with unreconstructable CIL. Eligible subjects will be randomized 1:1:1:1 to receive saline placebo or one of three dose/regimens of HGF plasmid DNA. The selection of outcome measures, including the primary endpoint, and changes in transcutaneous oxygen pressure (TcPO2) from baseline to 3 months will be discussed. In conclusion, this study will help to determine whether therapeutic angiogenesis with HGF is a viable option in the treatment of patients with CLI.
Original language | English (US) |
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Pages (from-to) | 193-198 |
Number of pages | 6 |
Journal | Vascular Medicine |
Volume | 9 |
Issue number | 3 |
DOIs | |
State | Published - 2004 |
Externally published | Yes |
Keywords
- Angiogenesis therapy
- Critical limb ischemia
- Gene transfer
- Vascular surgery
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine