Critical Limb IschemiaPhase 2NCT00651885
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
A Phase 2 study testing treprostinil dienthanolmine sustained release in people with Critical Limb Ischemia, run by Ochsner Health System at 1 site in United States.
Trial summary
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstructive surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- treprostinil dienthanolmine sustained release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2010
- Phase
- Phase 2
- 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
Who may be able to join
- Be 18 or older.
- Have an anticipated infra-popliteal endovascular intervention.
- Have a diagnosis of stage IIb- IVa (Fontaine) or stage 3- 5 (Rutherford scale) CLI due to documented peripheral arterial disease (Appendix E)
- If female, be physiologically incapable of childbearing or practicing acceptable methods of birth control.
- Have signed an appropriate informed consent for participation in this study.
Who cannot join
- Have had a previous endovascular intervention or stenting on the target limb.
- Be hemodynamically unstable, on hemodialysis for end stage renal failure, or have acute renal, cardiac or pulmonary failure.
- Have a history of intracranial bleeding, bleeding ulcer, urinary tract bleeding; or bleeding due to significant trauma within six weeks prior to study entry.
- Have a life-threatening malignancy requiring aggressive chemotherapy.
- Have any condition or laboratory value which, based on information in the UT-15C SR investigators' brochure, would constitute an unacceptable risk to the patient's safety, in the opinion of the investigator.
- Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial.
Show all 11Show fewer
- Have a known hypersensitivity to prostacyclin.
- Have participated in any investigational trial within 30 days of study drug initiation.
- Have been a non-responder to chronic (>30 days) prostanoid treatment, or have completed a chronic trial of prostanoid therapy within 30 days of study drug initiation.
- Be a pregnant or nursing woman.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an Infra-Popliteal Endovascular Intervention for the Treatment of Critical Limb Ischemia
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a last resort where limb salvage cannot be achieved. Despite the success of percutaneous intervention for small coronary vessels with lumen diameters less than 3 mm, similar techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and restenosis in as many as 50% of treated patients. As a result of the limited success, these percutaneous procedures have been reserved for the severest cases whereby limb loss is imminent without intervention. In this context, the sickest of all patients are enrolled in these trials and poor outcomes are common regardless of the intervention. Agents that promote intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet aggregation. These properties suggest that prostacyclin analogues such as treprostinil will be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of patients with CLI that can benefit from peripheral endovascular intervention. An orally available prostacyclin analogue could represent an important treatment advance in the prevention of restenosis following infrapopliteal angioplasty. In the present study, the safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo in patients with CLI undergoing an infra-popliteal endovascular intervention.
Read the detailed description
This study is a randomized, placebo controlled, single-center, evaluation of the safety and efficacy of UT-15C SR compared to placebo in patients with CLI with a planned infra-popliteal endovascular intervention procedure. Conventional therapy should be continued for all patients in the study. Conventional therapy is defined as the customary best medical practice at this investigative site for CLI, including analgesics for rest pain, debridement and wound care for ischemic wounds, etc., as long as such care meets the other requirements of the study and does not include prohibited therapies or investigational medications. A total of 20 patients will be prospectively randomized (1:1) to conventional treatment and placebo therapy in conjunction with an endovascular procedure or conventional treatment and UT-15C SR therapy in conjunction with an infrapopliteal endovascular procedure. Treatment is UT-15C sustained release (SR) tablets (1.0 mg dosage strength) or placebo. Treatment will be initiated at 1 mg twice daily with dose escalation of an additional 1 mg twice daily every 5 days if clinically indicated based upon the presence of known prostacyclin adverse events or adverse events that in the opinion of the investigator are attributable to UT-15C SR. Doses should be maximized throughout the Treatment Phase up to a maximum dose of 5 mg twice daily at the end of 12-weeks. Patients will return to the institution for the endovascular procedure at least 4 days after starting study drug and continue study drug, throughout the endovascular procedure and to Week 12. All patients will return to the clinic at Weeks 2, 6 and 12 for Treatment Phase assessments, and then Weeks 26 and 52 for follow-up assessments.
- Conditions
- Critical Limb Ischemia
- Being tested
- treprostinil dienthanolmine sustained release, Placebo
- Keywords
- UT-15C, Peripheral Vascular Disease, Treprostinil
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil dienthanolmine sustained releaseDrug
Also called UT-15C SR
UT-15C SR 1mg tablet
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 arm | Placebo comparator | Not described Receives: Drug: Placebo |
| 1 arm | Experimental | treprostinil dienthalomine Receives: Drug: treprostinil dienthanolmine sustained release |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability and safety of UT-15C SR as compared to placebo tablets in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
Measured: 12 weeks
Secondary outcomes (1)
To assess the efficacy of UT-15C SR as compared to placebo tablets on measures of clinical outcomes in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
Measured: 12-52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Sponsor
- Investigators
- Mark A Grise, M.D., Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651885
- Sponsor's protocol ID
- 2006.219.B
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2008
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an Infra-Popliteal Endovascular Intervention for the Treatment of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00651885
- Acronym / sponsor ID
- 2006.219.B
- Conditions
- Critical Limb Ischemia
- Keywords
- UT-15C, Peripheral Vascular Disease, Treprostinil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Apr 2008 (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.
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as percutaneous transluminal endovascular intervention, as well as reconstructive surgical procedures such as grafts or bypasses. Amputation is a last resort where limb salvage cannot be achieved. Despite the success of percutaneous intervention for small coronary vessels with lumen diameters less than 3 mm, similar techniques have had limited success in the lower extremity vessels. Infra-popliteal, or below the knee endovascular intervention, is commonly plagued by subacute thrombotic closure and restenosis in as many as 50% of treated patients. As a result of the limited success, these percutaneous procedures have been reserved for the severest cases whereby limb loss is imminent without intervention. In this context, the sickest of all patients are enrolled in these trials and poor outcomes are common regardless of the intervention. Agents that promote intracellular cAMP accumulation, including prostacyclin analogues and phosphodiesterase inhibitors, suppress smooth muscle proliferation, promote vasodilatation and inhibit platelet aggregation. These properties suggest that prostacyclin analogues such as treprostinil will be useful adjuncts to peripheral endovascular intervention and perhaps increase the number of patients with CLI that can benefit from peripheral endovascular intervention. An orally available prostacyclin analogue could represent an important treatment advance in the prevention of restenosis following infrapopliteal angioplasty. In the present study, the safety and efficacy of oral UT-15C sustained release (SR) tablets will be compared to placebo in patients with CLI undergoing an infra-popliteal endovascular intervention.
Detailed description
This study is a randomized, placebo controlled, single-center, evaluation of the safety and efficacy of UT-15C SR compared to placebo in patients with CLI with a planned infra-popliteal endovascular intervention procedure. Conventional therapy should be continued for all patients in the study. Conventional therapy is defined as the customary best medical practice at this investigative site for CLI, including analgesics for rest pain, debridement and wound care for ischemic wounds, etc., as long as such care meets the other requirements of the study and does not include prohibited therapies or investigational medications. A total of 20 patients will be prospectively randomized (1:1) to conventional treatment and placebo therapy in conjunction with an endovascular procedure or conventional treatment and UT-15C SR therapy in conjunction with an infrapopliteal endovascular procedure. Treatment is UT-15C sustained release (SR) tablets (1.0 mg dosage strength) or placebo. Treatment will be initiated at 1 mg twice daily with dose escalation of an additional 1 mg twice daily every 5 days if clinically indicated based upon the presence of known prostacyclin adverse events or adverse events that in the opinion of the investigator are attributable to UT-15C SR. Doses should be maximized throughout the Treatment Phase up to a maximum dose of 5 mg twice daily at the end of 12-weeks. Patients will return to the institution for the endovascular procedure at least 4 days after starting study drug and continue study drug, throughout the endovascular procedure and to Week 12. All patients will return to the clinic at Weeks 2, 6 and 12 for Treatment Phase assessments, and then Weeks 26 and 52 for follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 arm | Placebo comparator | Drug: Placebo |
| 1 arm | Experimental | Drug: treprostinil dienthanolmine sustained releasetreprostinil dienthalomine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be 18 or older.
- Have an anticipated infra-popliteal endovascular intervention.
- Have a diagnosis of stage IIb- IVa (Fontaine) or stage 3- 5 (Rutherford scale) CLI due to documented peripheral arterial disease (Appendix E)
- If female, be physiologically incapable of childbearing or practicing acceptable methods of birth control.
- Have signed an appropriate informed consent for participation in this study.
Key exclusion criteria (11 listed)
- Have had a previous endovascular intervention or stenting on the target limb.
- Be hemodynamically unstable, on hemodialysis for end stage renal failure, or have acute renal, cardiac or pulmonary failure.
- Have a history of intracranial bleeding, bleeding ulcer, urinary tract bleeding; or bleeding due to significant trauma within six weeks prior to study entry.
- Have a life-threatening malignancy requiring aggressive chemotherapy.
- Have any condition or laboratory value which, based on information in the UT-15C SR investigators' brochure, would constitute an unacceptable risk to the patient's safety, in the opinion of the investigator.
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 |
|---|---|---|
| treprostinil dienthanolmine sustained releaseAlso: UT-15C SRUT-15C SR 1mg tablet | Drug | 1 arm |
| PlaceboPlacebo | Drug | 2 arm |
Primary outcome
To assess the tolerability and safety of UT-15C SR as compared to placebo tablets in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
Time frame: 12 weeks
1 secondary outcome
To assess the efficacy of UT-15C SR as compared to placebo tablets on measures of clinical outcomes in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
Time frame: 12-52 weeks
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 24 Apr 2023.
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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.
Mark A Grise, M.D. principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treprostinil dienthanolmine sustained release in people with Critical Limb Ischemia, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the tolerability and safety of UT-15C SR as compared to placebo tablets in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure. (time frame: 12 weeks). 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 24 Apr 2023.