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COMPLETED

The Impact of Diabetes on REvascularization

NCT03085524 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 215 participants
Start Date 2017-08-01
Est. Completion 2022-10-01

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03085524

The ClinicalTrials.gov registry entry for NCT03085524 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03085524 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Michigan, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03085524?

The interventions under investigation include: Platelet function testing (DIAGNOSTIC_TEST), Vascular ultrasonography (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03085524?

This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial