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Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine


DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study




This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud`s phenomenon and promote healing of digital ulcers and other ischemic wounds.

Study Status: Completed


Condition Intervention Phase
Systemic Sclerosis
Drug: treprostinil diethanolamine
Drug: placebo
Phase 2

Verified by United Therapeutics January, 2011

Sponsored by: United Therapeutics
Information provided by: United Therapeutics identifier: NCT00775463

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic Foundation/Dept. of Rheumatologic and Immunologic Disease
Cleveland, Ohio 44195
United States

James Seibold, MD., Principal Investigator

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