Comparison of 2 iodinated contrast media about discomfort during angiographic evaluation in diabetic patients with critical limb ischemia.

Conditions: Critical limb ischemia in diabetic patients with wounds in the foot.
MedDRA version: 14.1Level: LLTClassification code 10012684Term: Diabetic peripheral vascular diseaseSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-005597-28-IT

Lead Sponsor: CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: After the first injection.;Main Objective: To compare the tolerance of two iodinated contrast media (CM) iodixanol 270 mgl/ml and ioversol 320 mg/ml during angiographic evaluation of peripheral arterial occlusive disease in diabetic patients with severe foot ulcers.;Secondary Objective: To compare the diagnostic efficiency of the iodixanol 270 mgl/ml and ioversol 320 mg/ml angiography of peripheral arterials.;Primary end point(s): Occurrence of injection-associated pain after the first injection.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Injection-associated pain, sensation of heat and movement due to CM injection and recorded after all injections.The diagnostic efficiency will be evaluated on the diagnostic confidence and on the enhancement basis. Safety will be evaluated based on immediate and retarded reactions.;Timepoint(s) of evaluation of this end point: At the end of the arteriography.