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NCT03085524 · ClinicalTrials.gov registry record
The Impact of Diabetes on REvascularization
A clinical trial of Diabetes Mellitus and Peripheral Arterial Disease, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 215
- Enrollment target
- 20
- Study locations
NCT03085524: Completed study of Diabetes Mellitus and Peripheral Arterial Disease, sponsored by Vanderbilt University Medical Center.
NCT03085524 is a study of Diabetes Mellitus and Peripheral Arterial Disease that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 215 participants, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03085524, a study of Diabetes Mellitus and Peripheral Arterial Disease, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 215 participants
- Enrollment target
- 20
- Study locations
Study Summary
The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascularization has determined the effect of diabetes on mechanism of revascularization failure. Therefore, this trial represents a unique opportunity to investigate the mechanisms by which diabetes affects surgical and endovascular revascularization procedures with the long-term goal of improving outcomes in CLI.
Primary Outcome
The combination of amputation, surgical revascularization, thrombectomy, thrombosis, interposition graft, or death
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Platelet function testing
- DIAGNOSTIC_TEST Vascular ultrasonography
Study Locations (20)
California
- Long Beach VA Medical Center - Long Beach
- Keck Medical Center of USC - Los Angeles
- San Francisco VA Medical Center - San Francisco
- University of California San Francisco Medical Center - San Francisco
Michigan
- Henry Ford Hospital - Detroit
- Michigan Vascular Center - Flint
- Michigan Heart - St. Joseph Mercy Health System - Ypsilanti
Illinois
- Loyola University Medical Center - Chicago
- Decatur Memorial Hospital - Decatur
Massachusetts
- Boston Medical Center - Boston
- University of Massachusetts Medical School - Worcester
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- University of Florida - Gainesville
Iowa
- Iowa Heart Center - West Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2022-10-01 |
What the finished NCT03085524 record still lists
NCT03085524 is an observational study that tracks outcomes without assigning an intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,866-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Platelet function testing is the first listed.
NCT03085524 names 20 study sites across 13 states, led by California, Michigan, Illinois.
Frequently Asked Questions
What is clinical trial NCT03085524 about?
NCT03085524 is a clinical study titled "The Impact of Diabetes on REvascularization". The presence of foot symptoms at rest or tissue necrosis in patients with peripheral artery disease is a medical urgency and represents a state of critical limb ischemia (CLI) where the risk of amputation, in the absence of revascularization, is high. No trial conducted to date in peripheral revascu...
What is the current status of trial NCT03085524?
This trial is currently completed. The enrollment target is 215 participants. The study started on 2017-08-01. Estimated completion is 2022-10-01.
What conditions does trial NCT03085524 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Peripheral Arterial Disease.
What interventions are being tested in trial NCT03085524?
The interventions under investigation include: Platelet function testing (DIAGNOSTIC_TEST), Vascular ultrasonography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03085524?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03085524 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03085524's enrollment target sits among peer trials
215 87th of 208 higher than 122 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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