Treatment of chronic critical lower limb ischemia with combination of surgical bypass operation and adenoviral VEGF-DdNdC intramuscular gene transfer A Randomized Single-Blinded Placebo-controlled Phase I-II Clinical Trial - KAT-PAD101

A.I.Virtanen Insitute, University of Kuopio0 个研究点开始时间: 2012年8月15日最近更新: 2012年10月29日

试验速览

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•informed consent signed, age over 60 years, chronic critical leg ischemia according to Rutherford and Fontaine classification (ischemic rest pain and regular requirement of analgesic and/or ischemic ulcer and/or toe gangrene) caused by severe PAOD, femoropopliteal or femorodistal surgical bypass is considered the most suitable treatment option as according to angiographic studies or MRA, palpable pulse in arteria femoralis communis in the operable leg, no prior proximal (thigh or femoral) amputation, stable pain or ischemic tissue lesion for at lest 2 weeks
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•patients with: acute limb ischemia, spreading leg infection, history or suspicion of malignant tumor, chronic immunosuppressive therapy, renal insuffiency (creatinin > 160 mg/l), NYHA 3-4 coronary artery disease, previous angiogenic growth factor / gene therapy, and patients that are not eligible for surgical bypass operation for any other reason

发起方

A.I.Virtanen Insitute, University of Kuopio