Clinical Trials Register

Summary
EudraCT Number:	2011-005597-28
Sponsor's Protocol Code Number:	DIADEMA
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-08
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005597-28

A.3

Full title of the trial

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.

Valutazione del Discomfort indotto dal Mezzo di Contrasto durante la valutazione angiografica dell'arteriopatia periferica occlusiva per definire l'approccio terapeutico per l'™angioplastica percutanea transluminale ( PTA ). Studio randomizzato prospettico, comparativo tra due mezzi di contrasto iodati.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Confronto tra 2 mezzi di contrasto iodati durante angiografia in relazione al discomfort in pazienti diabetici con ischemia critica agli arti inferiori.

A.4.1

Sponsor's protocol code number

DIADEMA

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GE HEALTHCARE s.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Casa di cura Abano Terme
B.5.2	Functional name of contact point	Radiologia interventistica
B.5.3	Address:
B.5.3.1	Street Address	Piazza C. Colombo, 1
B.5.3.2	Town/ city	Abano Terme
B.5.3.3	Post code	35031
B.5.3.4	Country	Italy
B.5.4	Telephone number	049-8221691
B.5.6	E-mail	marco.manzi@casacura.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	VISIPAQUE*270MG I/ML FL 500ML
D.2.1.1.2	Name of the Marketing Authorisation holder	GE HEALTHCARE Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IODIXANOL
D.3.9.1	CAS number	92339-11-2
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB08213MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	550
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	CHIMICO
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OPTIRAY*EV 100ML 320MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	COVIDIEN ITALIA SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarterial use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IOVERSOL
D.3.9.1	CAS number	87771-40-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB08262MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	320
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	chimico

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Critical limb ischemia in diabetic patients with wounds in the foot.

Ischemia critica agli arti inferiori in pazienti diabetici portatori di lesioni trofiche al piede

E.1.1.1

Medical condition in easily understood language

Diabetic patients with wound diabetic foot.

Pazienti diabetici con lesioni in piede diabetico

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10012684
E.1.2	Term	Diabetic peripheral vascular disease
E.1.2	System Organ Class	10047065 - Vascular disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

Confrontare la tollerabilità di due mezzi di contrasto iodati (CM) iodixanolo 270 mgl/ml e ioversolo 320 mg/ml durante la valutazione diagnostica DSA prima della PTA della arteriopatia periferica occlusiva nei pazienti con ulcere severe del piede.

E.2.2

Secondary objectives of the trial

To compare the diagnostic efficiency of the iodixanol 270 mgl/ml and ioversol 320 mg/ml angiography of peripheral arterials.

Confrontare l’efficacia diagnostica dello iodixanolo 270 mgI/ml e dello ioversolo 320 mg/ml nella angiografia delle arterie periferiche.

E.2.3

Trial contains a sub-study

E.3

Principal 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).

148 pazienti (età > 18 anni ) abilitati per l’arruolamento nello studio saranno uomini o donne di qualunque provenienza etnica con diagnosi di malattia del piede diabetico definita dai membri del team di questo centro. Le donne in età fertile dovranno presentare test di gravidanza negativo inferiore ai 7 giorni prima della procedura, requisito necessario per eseguire l’indagine angiografica, disponibili a usare un contracettivo affidabile per tutta la durata di partecipazione allo studio. I pazienti da sottoporre alla DSA prima della PTA con piede diabetico dovranno avere, al momento del ricovero in ospedale, lesioni appartenenti al grado 4-6 secondo la scala di Rutherford (9), in particolare soggetti diabetici con dolore a riposo (grado 4), ulcerazione ischemica con ulcera non-superiore delle dita del piede (grado 5), o gravi ulcere ischemiche o gangrena franca (grado 6).

E.4

Principal exclusion criteria

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

Saranno esclusi da questo studio i pazienti con complicanze del piede con eziologie non correlate al diabete .

E.5 End points

E.5.1

Primary end point(s)

Occurrence of injection-associated pain after the first injection.

Discomfort del paziente definito come comparsa del dolore associato all’iniezione dopo la prima somministrazione.

E.5.1.1

Timepoint(s) of evaluation of this end point

After the first injection.

Dopo la prima iniezione.

E.5.2

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.

Discomfort come calore e dolore dopo tutte le iniezioni. L’efficacia diagnostica sara’ valutata sulla base della affidabilita’ diagnostica. La sicurezza sara’ valutata sulla base dell’incidenza delle reazioni immediate e ritardate.

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the arteriography.

Dopo l'arteriografia.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

''LVLS''

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

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:

118

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

148

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will be treated for diabetic complications.

I pazienti saranno seguiti secondo le procedure previste per le complicanze del diabete.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-04-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-15

P. End of Trial
P.	End of Trial Status	Ongoing

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