Clinical trial NCT01718288: Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)
Official title: Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb), Unsuitable or Suitable to Surgical Revascularization / Endovascular With Reference to the Change of Pain-free Walking Distance and Other Endpoints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: PAD; iloprost; walking distance; cardiovascular events
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the possibility of optimization of therapy with prostanoids (iloprost), in patients with Fontaine's stage IIb severe chronic ischemia, both in patients eligible for surgery both in patients for which it is only possible medical therapy

Detailed description: The management of patients with peripheral arterial disease (PAD) stage IIb and pain-free walking distance (PFWD) less than 100 meters is a major clinical problem, in view of the significant cooling of the quality of life and evolution often severe that characterizes the clinical course of these patients. Revascularization Surgery is the treatment of choice, but about half of patients with severe PAD IIb is not eligible for surgery or endovascular treatment. The usefulness of use of vasodilators or hemorheological is controversial, and medical treatment of these patients is therefore heterogeneous understanding the various pharmacologic options (for the correction of risk factors, prevention of cardiovascular events, improvement of claudication), and rehabilitative programs. Iloprost, a synthetic analogue of prostacyclin, is effective in the treatment of patients with chronic critical ischemia, and its pharmacological profile (effective vasodilator, anti-platelet, and leukocyte activation) is particularly suitable to modulate multiple components pathogenesis of peripheral arterial disease. Specifically, in the treatment of patients with PAD IIb severe, the current state is available only a retrospective study that compared the use of iloprost with that of vasodilators. Aim of the study FADOI-2bPILOT is to evaluate prospectively and for an observation period of 13 months, if you can get a benefit on the pain-free walking distance and on clinical outcome from "anticipated" and additional use of iloprost, in patients with severe IIb stage PAD treated according to current "best medical practice".

Eligibility criteria: Inclusion Criteria: age \> 18 years; pain-free walking distance (PFWD) \<100 meters on two occasions 10 days apart, with \<25% difference between each other; ankle blood pressure (BP) \<70 mmHg; big toe BP \< 30 mmHg (in case of diabetic patient).

Exclusion Criteria: pain at rest, trophic ulcers or gangrene (critical limb ischemia), if they were unable to cooperate, or one of the following conditions (contraindications or precautions for use of iloprost) was present: myocardial infarction or stroke in the previous 6 months; congestive heart failure NYHA class \>II; unstable angina; uncontrolled severe arterial hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg) or hypotension (systolic BP \<90 mmHg); hyperkinetic ventricular arrhythmia; acute pulmonary edema or pulmonary congestion; bleeding diathesis; platelet count \<80,000 or \> 500,000/mm3; renal failure requiring dialysis; liver cirrhosis; pregnancy or breast feeding; history of allergy, hypersensitivity or intolerance to iloprost or other prostanoids.

Primary outcomes:
measure: Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD
timeFrame: 13 months
Secondary outcomes:
measure: Assessing changes in endurance
timeFrame: 13 months
measure: The possible occurrence of major complications
timeFrame: 13 months
measure: Quality of life
timeFrame: 13 months
Other outcomes:
Locations:
city: Mercato San Severino
country: Italy
facility: Angiology, Hospital "G. Fucito"
state: Salerno
city: Bari
country: Italy
facility: Internal Medicine, Hospital "Policlinico"
city: Catania
country: Italy
facility: Angiology, Hospital "Ferrarotto - Alessi"
city: Catanzaro
country: Italy
facility: Internal Medicine, Hospital "Pugliese - Ciaccio"
city: Fermo
country: Italy
facility: Internal Medicine, Hospital of Fermo
city: Genoa
country: Italy
facility: Vascular Surgery, Hospital "Galliera"
city: Legnano
country: Italy
facility: Internal Medicine, Hospital Civile
city: Matera
country: Italy
facility: Internal Medicine, "Madonna delle Grazie" Hospital
city: Naples
country: Italy
facility: Internal Medicine, Hospital "Fatebenefratelli"
city: Naples
country: Italy
facility: Surgery Dept., Hospital " San Giovanni Bosco"
city: Reggio Calabria
country: Italy
facility: Internal Medicine, Hospital "Bianchi Melacrino Morelli"
city: Rome
country: Italy
facility: Internal Medicine, Hospital Policlinico Campus Biomedico
city: Varese
country: Italy
facility: Internal Medicine, Hospital "Fondazione Circolo Macchi"
city: Vibo Valentia
country: Italy
facility: Internal Medicine, Hospital "Jazzolino"
Study officials:
affiliation: Fadoi Foundation
name: Gualberto Gussoni, MD, PhD
role: STUDY_DIRECTOR
References: