Peripheral Arterial Disease Clinical Trial
— 2bPILOTOfficial 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
Verified date | October 2012 |
Source | Fadoi Foundation, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Internal Medicine, Hospital "Policlinico" | Bari | |
Italy | Angiology, Hospital "Ferrarotto - Alessi" | Catania | |
Italy | Internal Medicine, Hospital "Pugliese - Ciaccio" | Catanzaro | |
Italy | Internal Medicine, Hospital of Fermo | Fermo | |
Italy | Vascular Surgery, Hospital "Galliera" | Genoa | |
Italy | Internal Medicine, Hospital Civile | Legnano | |
Italy | Internal Medicine, "Madonna delle Grazie" Hospital | Matera | |
Italy | Angiology, Hospital "G. Fucito" | Mercato San Severino | Salerno |
Italy | Internal Medicine, Hospital "Fatebenefratelli" | Naples | |
Italy | Surgery Dept., Hospital " San Giovanni Bosco" | Naples | |
Italy | Internal Medicine, Hospital "Bianchi Melacrino Morelli" | Reggio Calabria | |
Italy | Internal Medicine, Hospital Policlinico Campus Biomedico | Rome | |
Italy | Internal Medicine, Hospital "Fondazione Circolo Macchi" | Varese | |
Italy | Internal Medicine, Hospital "Jazzolino" | Vibo Valentia |
Lead Sponsor | Collaborator |
---|---|
Fadoi Foundation, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD | Aim of this multicenter, randomized, controlled study was prospectively evaluate the effects of iloprost, added to standard therapy, in patients with 2b stage PAD and PFWD (pain-free walking distance) less than 100 metres, eligible and non-eligible for surgical revascularization. A treadmill test 3-6-9-12 months (before iloprost cycle for patients group 1B and 2B). A final evaluation 13 months (for one month to the conclusion of the 12 months treatment of iloprost for patients group 1B and 2B, and after 13 months from enrolling for patients in the study group 1A and 2A) | 13 months | Yes |
Secondary | Assessing changes in endurance | A clinical evaluation 3-6-9-12 months (before iloprost cycle for patients group 1B and 2B). A final evaluation 13 months (for one month to the conclusion of the 12 months treatment of iloprost for patients group 1B and 2B, and after 13 months from enrolling for patients in the study group 1A and 2A) | 13 months | Yes |
Secondary | The possible occurrence of major complications | The study reported the number of events during all the study (13 months). The major complication were: Ischemic cardiopathy, critical limb ischemia, cerebrovascular event, critical limb ischemia | 13 months | Yes |
Secondary | Quality of life | For the Quality of life, the study used a specific questionnaire administrated to all patients enrolled in the study (13 months of observation): IQOLA (International Quality of Life Assessment),SF-36 Italian Version 1.6 | 13 months | Yes |
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