Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease

Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00053716

Enrollment

Registered

2003-02-06

Start date

2003-02-28

Completion date

2003-08-31

Last updated

2007-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

Keywords

Angioplasty & PGE1 Treatment of Peripheral Vascular Disease

Brief summary

This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

Detailed description

PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers. Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure. A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX. Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20

Interventions

DRUGLiprostin [liposomal Prostaglandin E1]

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects, 18 years and older * Diagnosis of Peripheral Arterial Occlusive Disease \[PAOD\] * Subject is a candidate for immediate angioplasty of the lower limb * Subject must complete 2 treadmill tests at Screen in which walking distance is limited by PAOD and not due to angina or fatigue

Exclusion criteria

* Lower limb peripheral re-vascularization procedures in past 3 months * History of myocardial infarction in the past 6 months * Malignant disease, uncontrolled hypertension or Class III heart failure * Aortic occlusion, thrombosed popliteal aneurysm, severe hemorrhagic disorder, or a long iliac occlusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026