Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

March 31, 2011

Study Completion Date

April 30, 2012

Conditions
Peripheral Arterial Disease
Interventions
DRUG

iloprost

"The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).~For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.~The 4 groups:~1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment~1. B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment~2. A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment~2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment"

DRUG

Standard Treatment (aspirin.....),

"The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.~correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids"

Trial Locations (14)

16128

"Vascular Surgery, Hospital Galliera", Genoa

20025

Internal Medicine, Hospital Civile, Legnano

21100

"Internal Medicine, Hospital Fondazione Circolo Macchi", Varese

63900

Internal Medicine, Hospital of Fermo, Fermo

70124

"Internal Medicine, Hospital Policlinico", Bari

75100

"Internal Medicine, Madonna delle Grazie Hospital", Matera

80123

"Internal Medicine, Hospital Fatebenefratelli", Naples

80144

"Surgery Dept., Hospital San Giovanni Bosco", Naples

84085

"Angiology, Hospital G. Fucito", Mercato San Severino

88100

"Internal Medicine, Hospital Pugliese - Ciaccio", Catanzaro

89100

"Internal Medicine, Hospital Bianchi Melacrino Morelli", Reggio Calabria

89900

"Internal Medicine, Hospital Jazzolino", Vibo Valentia

95100

"Angiology, Hospital Ferrarotto - Alessi", Catania

00155

Internal Medicine, Hospital Policlinico Campus Biomedico, Rome

All Listed Sponsors
lead

Fadoi Foundation, Italy

OTHER

NCT01718288 - Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb) | Biotech Hunter | Biotech Hunter