Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft

United Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Peripheral Vascular Disease

Treatments: Drug: Remodulin (treprostinil sodium) Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00067041

REM03:203

Details and patient eligibility

About

Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patients with critical limb ischemia and an appropriate reference lower-limb ischemic wound due to documented peripheral arterial disease who have had an autogenous vein infrainguinal bypass graft performed immediately prior to study initiation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind