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The Impact of Diabetes on REvascularization

NCT03085524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215

Last updated 2024-07-08

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

Platelet function testing

The investigators will test platelet reactivity at the beginning and midpoint of the first year after revascularization

DIAGNOSTIC_TEST

Vascular ultrasonography

The investigators will test bypass graft and stent patency at 30 days, 6 months, and 1 year.

Sponsors & Collaborators

  • Carelon Research

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2021-10-01
Completion
2022-10-01

Countries

  • United States
  • Canada
  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085524 on ClinicalTrials.gov