Source:http://linkedlifedata.com/resource/pubmed/id/15675184
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
3
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pubmed:dateCreated |
2005-1-28
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pubmed:abstractText |
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 study in 100 patients with unreconstructable CLI. 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.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
May
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pubmed:issn |
1358-863X
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
9
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
193-8
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pubmed:dateRevised |
2007-11-15
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pubmed:meshHeading |
pubmed-meshheading:15675184-Adult,
pubmed-meshheading:15675184-Dose-Response Relationship, Drug,
pubmed-meshheading:15675184-Double-Blind Method,
pubmed-meshheading:15675184-Female,
pubmed-meshheading:15675184-Follow-Up Studies,
pubmed-meshheading:15675184-Hepatocyte Growth Factor,
pubmed-meshheading:15675184-Humans,
pubmed-meshheading:15675184-Ischemia,
pubmed-meshheading:15675184-Lower Extremity,
pubmed-meshheading:15675184-Male,
pubmed-meshheading:15675184-Neovascularization, Physiologic,
pubmed-meshheading:15675184-Peripheral Vascular Diseases,
pubmed-meshheading:15675184-Randomized Controlled Trials as Topic,
pubmed-meshheading:15675184-Regional Blood Flow,
pubmed-meshheading:15675184-Research Design,
pubmed-meshheading:15675184-Treatment Outcome
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pubmed:year |
2004
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pubmed:articleTitle |
Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial.
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pubmed:affiliation |
Division of Vascular Surgery, Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. Richard.J.Powell@Hitchcock.org
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pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't
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