دورية أكاديمية
Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia:A double-blind randomized trial
| العنوان: | Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia:A double-blind randomized trial |
|---|---|
| المؤلفون: | Kusumanto, YH, Van Weel, V., Mulder, NH, Smit, AJ, Van den Dungen, JJAM, Hooymans, JMM, Sluiter, WJ, Tio, RA, Quax, PHA, Gans, ROB, Dullaart, RPF, Hospers, GAP |
| المصدر: | Kusumanto , YH , Van Weel , V , Mulder , NH , Smit , AJ , Van den Dungen , JJAM , Hooymans , JMM , Sluiter , WJ , Tio , RA , Quax , PHA , Gans , ROB , Dullaart , RPF & Hospers , GAP 2006 , ' Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia : A double-blind randomized trial ' , Human Gene Therapy , vol. 17 , no. 6 , pp. 683-691 . https://doi.org/10.1089/hum.2006.17.683Test |
| سنة النشر: | 2006 |
| المجموعة: | University of Groningen research database |
| مصطلحات موضوعية: | QUALITY-OF-LIFE, PERIPHERAL ARTERIAL-DISEASE, LOWER-EXTREMITY ISCHEMIA, CRITICAL LEG ISCHEMIA, THERAPEUTIC ANGIOGENESIS, PHASE-II, PHVEGF(165), AMPUTATIONS, STANDARDS |
| الوصف: | Despite advances in revascularization techniques, limb salvage and relief of pain cannot be achieved in many diabetic patients with diffuse peripheral vascular disease. Our objective was to determine the effect of intramuscular administration of phVEGF(165) (vascular endothelial growth factor gene-carrying plasmid) on critical limb ischemia (CLI) compared with placebo (0.9% NaCl). A double-blind, placebo-controlled study was performed in 54 adult diabetic patients with CLI. The primary end point was the amputation rate at 100 days. Secondary end points were a 15% increase in pressure indices (ankle-to-brachial index and toe-to-brachial index), clinical improvement (skin, pain, and Quality of Life score), and safety. In patients (n = 27) treated with placebo versus phVEGF(165)-treated patients (n=27) the following results were found: 6 amputations versus 3 (p = not significant [NS]); hemodynamic improvement in 1 versus 7 (p = 0.05); improvement in skin ulcers, 0 versus 7 (p = 0.01); decrease in pain, 2 versus 5 (p = NS); and overall, 3 versus 14 responding patients (p = 0.003). No grade 3 or 4 adverse effects were seen in these patients. We conclude that this small, randomized gene therapy study failed to meet the primary objective of significant amputation reduction. However, significant and meaningful improvement was found in patients treated with a VEGF(165)-containing plasmid. There were no substantial adverse events. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://research.rug.nl/en/publications/a91065b0-2184-4f9e-857b-854e250542f9Test |
| DOI: | 10.1089/hum.2006.17.683 |
| الإتاحة: | https://doi.org/10.1089/hum.2006.17.683Test https://hdl.handle.net/11370/a91065b0-2184-4f9e-857b-854e250542f9Test https://research.rug.nl/en/publications/a91065b0-2184-4f9e-857b-854e250542f9Test https://pure.rug.nl/ws/files/191076434/hum.2006.17.683.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.984FECDA |
| قاعدة البيانات: | BASE |
| DOI: | 10.1089/hum.2006.17.683 |
|---|