PARC-Rem: Remodulin - Clinical Limb Ischemia Clinical Trial
Study of:
Remodulin
The purpose of this trial is to assess the safety of subcutaneous Remodulin therapy in patients with chronic limb ischemia with no planned interventional procedures and to determine the effect of Remodulin on wound healing and treadmill walk distance. The secondary objectives are to assess the effect of Remodulin on rest pain, limb salvage, mortality, quality of life and ambulatory and living status in chronic limb ischemia patients.
Remodulin is a vasodilator it opens the blood vessels down to the capillary beds. Remodulin has a very short half-life of 2-4 hours and must be administered by intravenous infusion. This drug is administered by continuous subcutaneous infusion using pager-sized mini-med syringe infusion pump. This is a randomized study. The patient could either receive the drug or a placebo with 2:1 odds. They will also be randomized for either a continuous or a daily dosing, which involves receiving the drug 12 hours out of the day.
Remodulin is a prostacyclin that is approved in the United States for chronic, continuous subcutaneous infusion in patients with pulmonary hypertension. In a previous trial, acute intravenous Remodulin was well tolerated in a small study in patients with severe daily claudication and produced potentially clinically significant increases in lower limb blood flow in these patients.
For more information about this study or other research studies at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Vicki Pink at 612-863-6286. |