Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
Public ClinicalTrials.gov record NCT00775463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00775463
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 148 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2009 (Type not available)
- Primary completion
- Mar 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Dec 28, 2023
2009 – 2011
United States locations
- U.S. sites
- 24
- U.S. states
- 21
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Arthritis Clinical Intervention Program | Birmingham | Alabama | 35294 | — |
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Stanford University School of Medicine/Palo Alto VA Health Care System | Palo Alto | California | 94304 | — |
| Denver Medical Center | Aurora | Colorado | 80045 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Northwestern University - Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Indiana School of Medicine | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins University - Division of Rheumatology | Baltimore | Maryland | 21224 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| University of Michigan Scleroderma Program | Ann Arbor | Michigan | 48106 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| UMDNJ Clinical Research Center | New Brunswick | New Jersey | 08903 | — |
| North Shore-LIJ Health System | Lake Success | New York | 11042 | — |
| The Hospital for Special Surgery | New York | New York | 10021 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas - Houston | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98111 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00775463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 28, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00775463 live on ClinicalTrials.gov.