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NCT05063474 · ClinicalTrials.gov registry record

Microvascular Reactivity in Peripheral Artery Disease

A clinical trial, sponsored by Columbia University.

Terminated
Registry status
3
Enrollment target

NCT05063474: Clinical Trial study, sponsored by Columbia University.

NCT05063474 is a clinical trial that was terminated before completion, run by Columbia University. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05063474 was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
3 participants
Enrollment target

Study Summary

Peripheral Artery Disease (PAD) is a major risk factor for lower limb amputation. Microvascular reactivity assessed with near-infrared spectrometry has been studied in people with PAD but not in people with limb loss (PLL) who have PAD. The purpose of this research is to explore whether near-infrared spectrometry measures can contribute to identifying people at risk for amputation. Specific aims include: 1) Determine the test-retest reliability of near-infrared spectrometry measures in people with peripheral artery disease with or without major unilateral amputation. 2) Determine construct validity of near-infrared spectrometry measures compared to 6-Minute Walk Test, and time to claudication onset; and self-reported prosthetic mobility in people with transtibial amputation. This methodologic prospective study with repeated assessments and long term phone follow-up every year to identify any subjects that undergo revascularization or amputation will include 2 groups of subjects: a PAD group enrolled from an out-patient walking program, and a PLL+PAD group who receive no care but have their walking step counts monitored.

Primary Outcome

Near Infrared Spectrometry

Interventions

  • DIAGNOSTIC_TEST No Intervention-Clinical Assessments only

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-11-09
Est. Completion 2023-04-24
Columbia University

958 total trials

Why NCT05063474 stopped before completion

NCT05063474 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which No Intervention-Clinical Assessments only is the first listed.

NCT05063474 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05063474 about?

NCT05063474 is a clinical study titled "Microvascular Reactivity in Peripheral Artery Disease". Peripheral Artery Disease (PAD) is a major risk factor for lower limb amputation. Microvascular reactivity assessed with near-infrared spectrometry has been studied in people with PAD but not in people with limb loss (PLL) who have PAD. The purpose of this research is to explore whether near-infrare...

What is the current status of trial NCT05063474?

This trial is currently terminated. The enrollment target is 3 participants. The study started on 2021-11-09. Estimated completion is 2023-04-24.

What interventions are being tested in trial NCT05063474?

The interventions under investigation include: No Intervention-Clinical Assessments only (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05063474?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05063474, the US trial registry maintained by the National Library of Medicine. NCT05063474 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.