Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

United Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Foot Ulcers; Peripheral Vascular Disease; Critical Limb Ischemia; Rest Leg Pain

Treatments: Drug: Remodulin® (treprostinil sodium) Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00060996

REM 03:202

Details and patient eligibility

About

The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with Stage III or IV critical limb ischemia due to documented peripheral arterial disease with no planned interventional vascular procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind