NCT03490968

Brief Summary

Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

5.3 years

First QC Date

March 30, 2018

Last Update Submit

February 27, 2024

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

  • C3/C5acylcarnitine levels in healthy control subjects.

    baseline

  • C3/C5acylcarnitine levels in PAD exercise group after 12 weeks

    Change from baseline to 12 weeks

  • C3/C5 acylcarnitine levels in PAD surgical bypass group

    Change from baseline to 12 weeks

Study Arms (3)

Healthy Subjects

OTHER
Behavioral: Vascular Assessment

Peripheral Artery Disease (PAD) with Supervised Exercise

EXPERIMENTAL

Subjects will be referred for supervised exercise therapy. Subjects will have 3 visits per week for 12 weeks. Each visit will include a minimum of 30 to 40 minutes of exercise to improve ambulation with a certified trainer.

Behavioral: Supervised ExerciseBehavioral: Vascular Assessment

PAD Subjects Who Undergo Revascularization of the Leg

ACTIVE COMPARATOR

This group of subjects are receiving leg revascularization as part of standard of care.

Behavioral: Vascular Assessment

Interventions

Supervised ExerciseBEHAVIORAL

Subjects will have 3 visits per week for 12 weeks.

Peripheral Artery Disease (PAD) with Supervised Exercise
Vascular AssessmentBEHAVIORAL

Screen: Subjects will undergo a H\&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age. Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy. Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.

Healthy SubjectsPAD Subjects Who Undergo Revascularization of the LegPeripheral Artery Disease (PAD) with Supervised Exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Male or female, age ≥ 50 years old
  • Non-smoker
  • Presence of peripheral artery disease
  • History of a heart attack or stroke
  • Diabetes
  • Active cancer
  • Severe renal disease (CrCl \< 60)
  • Severe liver disease
  • Active rheumatological diseases
  • Male or female, age 50 years or older
  • Atherosclerotic PAD, ABI ≤0.85
  • Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
  • For Aim 3, subjects will have Rutherford stage 4 or 5 disease
  • For Aim 3, subjects will be undergoing revascularization as standard of care
  • Presence of a femoral, popliteal or tibial aneurysm of the index limb
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Sullivan AE, Behroozian A, Coolbaugh C, Shardelow E, Smith EK, Wells QS, Clair DG, Aday AW, Garrard CL 3rd, Curci JA, Holder TA, Barnett JV, Freiberg MS, Crescenzi RL, Wakeham DJ, Hearon CM Jr, Donahue MJ, Beckman JA. Microvascular Function and Ambulatory Capacity in Peripheral Artery Disease. Circ Cardiovasc Interv. 2025 Oct;18(10):e015582. doi: 10.1161/CIRCINTERVENTIONS.125.015582. Epub 2025 Sep 4.

    PMID: 40905129DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Joshua Beckman, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2018

First Posted

April 6, 2018

Study Start

May 22, 2018

Primary Completion

August 22, 2023

Study Completion

August 22, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

US(1)