Peripheral Arterial DiseasePhase 42bPILOTNCT01718288
Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)
A Phase 4 study testing iloprost and Standard Treatment (aspirin.....), in people with Peripheral Arterial Disease, run by Fadoi Foundation, Italy at 14 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- iloprost and Standard Treatment (aspirin.....),
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesItaly
- Study dates
- Nov 2006to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Internal Medicine, Hospital "Policlinico"
Bari, 70124
Angiology, Hospital "Ferrarotto - Alessi"
Catania, 95100
Internal Medicine, Hospital "Pugliese - Ciaccio"
Catanzaro, 88100
Internal Medicine, Hospital of Fermo
Fermo, 63900
Vascular Surgery, Hospital "Galliera"
Genoa, 16128
Internal Medicine, Hospital Civile
Legnano, 20025
Internal Medicine, "Madonna delle Grazie" Hospital
Matera, 75100
Angiology, Hospital "G. Fucito"
Mercato San Severino, Salerno, 84085
Internal Medicine, Hospital "Fatebenefratelli"
Naples, 80123
Surgery Dept., Hospital " San Giovanni Bosco"
Naples, 80144
Internal Medicine, Hospital "Bianchi Melacrino Morelli"
Reggio Calabria, 89100
Internal Medicine, Hospital Policlinico Campus Biomedico
Rome, 00155
Internal Medicine, Hospital "Fondazione Circolo Macchi"
Varese, 21100
Internal Medicine, Hospital "Jazzolino"
Vibo Valentia, 89900
About this study
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
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
Read the 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".
- Conditions
- Peripheral Arterial Disease
- Being tested
- iloprost, Standard Treatment (aspirin.....),
- Keywords
- PAD; iloprost; walking distance; cardiovascular events
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprostDrug
Also called ENDOPROST*0,05MG/0,5ML 1F
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
- B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment
- 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
Standard Treatment (aspirin.....),Drug
Also called aspirin, antiplatelet, statins,hemorheological/vasodilators
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
| Study group | Role | What they receive |
|---|---|---|
| iloprost + standard treat.(aspirin) | Experimental | 1B - patients unsuitable to surgical or endovascular vascular therapy: treatment with iloprost intravenous infusions for 10 days every 3 months, in addition to conventional treatment Receives: Drug: iloprost; Drug: Standard Treatment (aspirin.....), |
| Standard Treatment (aspirin....) | Active comparator | 1A - patients unsuitable to surgical or endovascular vascular therapy: conventional treatment
Conventional Treatments: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 Receives: Drug: Standard Treatment (aspirin.....), |
| Vascular surgery patients + iloprost | Experimental | 2B - patients suitable to vascular surgical or endovascular therapy: treatment with intravenous infusions iloprost for 10 days every 3 months, in addition to conventional treatment Receives: Drug: iloprost; Drug: Standard Treatment (aspirin.....), |
| Vasc. Surg.+ standard treat. (aspirin..) | Active comparator | 2A - patients suitable to vascular surgical or endovascular therapy + standard treatment (aspirin...) Receives: Drug: Standard Treatment (aspirin.....), |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 13 months
Secondary outcomes (3)
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)
Measured: 13 months
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
Measured: 13 months
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
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2006
- Primary completionMar 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gualberto Gussoni, MD, PhD, Study director, Fadoi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718288
- Sponsor's protocol ID
- Eudract Number: 2006-001660-23
- Acronym
- 2bPILOT
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01718288
- Acronym / sponsor ID
- 2bPILOT / Eudract Number: 2006-001660-23
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD; iloprost; walking distance; cardiovascular events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iloprost + standard treat.(aspirin) | Experimental | Drug: iloprost, Drug: Standard Treatment (aspirin.....),1B - patients unsuitable to surgical or endovascular vascular therapy: treatment with iloprost intravenous infusions for 10 days every 3 months, in addition to conventional treatment |
| Standard Treatment (aspirin....) | Active comparator | Drug: Standard Treatment (aspirin.....),1A - patients unsuitable to surgical or endovascular vascular therapy: conventional treatment Conventional Treatments: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 |
| Vascular surgery patients + iloprost | Experimental | Drug: iloprost, Drug: Standard Treatment (aspirin.....),2B - patients suitable to vascular surgical or endovascular therapy: treatment with intravenous infusions iloprost for 10 days every 3 months, in addition to conventional treatment |
| Vasc. Surg.+ standard treat. (aspirin..) | Active comparator | Drug: Standard Treatment (aspirin.....),2A - patients suitable to vascular surgical or endovascular therapy + standard treatment (aspirin...) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloprostAlso: ENDOPROST*0,05MG/0,5ML 1FThe 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 | Vascular surgery patients + iloprost, iloprost + standard treat.(aspirin) |
| Standard Treatment (aspirin.....),Also: aspirin, antiplatelet, statins,hemorheological/vasodilatorsThe 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 | Drug | Standard Treatment (aspirin....), Vasc. Surg.+ standard treat. (aspirin..), Vascular surgery patients + iloprost, iloprost + standard treat.(aspirin) |
Primary outcome
Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD
Time frame: 13 months
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)
3 secondary outcomes
Assessing changes in endurance
Time frame: 13 months
The possible occurrence of major complications
Time frame: 13 months
Quality of life
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gualberto Gussoni, MD, PhD study director
Fadoi Foundation
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iloprost and Standard Treatment (aspirin.....), in people with Peripheral Arterial Disease, run by Fadoi Foundation, Italy at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of PFWD(pain-free walking distance)in patients with 2b stage PAD (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.