Evaluation of the Discomfort Contrast Induced during Angiographic evaluation of peripheral arterial occlusive disease to define the treatment approach for percutaneous transluminal balloon angioplasty (PTA). Randomized prospective trial, comparing two iodinated contrast media.

CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE0 个研究点开始时间: 2012年3月8日最近更新: 2012年5月23日

适应症

试验速览

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•The 148 (>18 years) patients selected for entry into this study will be men or women of any ethnic background diagnosed with diabetic foot disease by members of the team of this centre. Women of childbearing age must have a negative pregnancy test less than 7 days before the procedure, available to use a reliable contraceptive for the duration of study participation. Angiography of patients with diabetic foot having admission to the hospital, lesions classified according to Rutherford Scale (9), in particular diabetic subjects with pain at rest or less deep ulceration (grade 4), ischemic ulceration of the toes (grade 5), or severe ischemic ulcers or gangrene (Grade 6).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 118

•Patients with complications of the foot with etiologies not related to diabetes will be excluded from this study.

发起方

CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE