Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Summary

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.

Timeline

Start

2009-05

Primary completion

2011-03

Completion

2011-07

Publications

• Mecoli CA, Perin J, Van Eyk JE, Zhu J, Fu Q, Allmon AG, Rao Y, Zeger S, Wigley FM, Hummers LK, Shah AA. Vascular biomarkers and digital ulcerations in systemic sclerosis: results from a randomized controlled trial of oral treprostinil (DISTOL-1). Clin Rheumatol. 2020 Apr;39(4):1199-1205. doi: 10.1007/s10067-019-04863-0. Epub 2019 Dec 19.

Drugs

Indications