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Microvascular Reactivity in Peripheral Artery Disease

NCT05063474 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2024-05-30

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

No Intervention-Clinical Assessments only

No Intervention. Clinical Assessments include: vital signs, near infrared spectrometry, general leg strength, and 6-minute walking test.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Columbia University

    lead OTHER

Principal Investigators

  • Christopher K Wong, PhD, PT · Columbia University

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2023-04-24
Completion
2023-04-24

Countries

  • United States

Study Locations

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Diseases
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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 NCT05063474 on ClinicalTrials.gov