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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005597-28-IT
Enrollment
Unknown
Registered
2012-03-08
Start date
2012-04-10
Completion date
Unknown
Last updated
2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical limb ischemia in diabetic patients with wounds in the foot. MedDRA version: 14.1 Level: LLT Classification code 10012684 Term: Diabetic peripheral vascular disease System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: VISIPAQUE*270MG I/ML FL 500ML Pharmaceutical Form: Solution for injection INN or Proposed INN: IODIXANOL CAS Number: 92339-11-2 Other descriptive name: NA Concentration unit: mg/ml milligr

Sponsors

CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

Italy

Contacts

Public ContactRadiologia interventistica

Casa di cura Abano Terme

marco.manzi@casacura.it049-8221691

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026