Major study tracks PAD Patients' quality of life over a year
NCT ID NCT01419080
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed nearly 800 people with peripheral artery disease (PAD) for one year to see how different treatments affect their symptoms, daily function, and quality of life. Researchers measured health status using a special questionnaire and looked for differences based on age, gender, race, and income. The goal was to find ways to improve care for all PAD patients.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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797 people
The number who actually took part.
- Started
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Oct 2013
- Finished
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Dec 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting to a PAD specialty clinic with new-onset exertional leg symptoms, or recent exacerbations of symptoms, will be screened for enrollment at 10 specialty PAD clinics. Trained study coordinators will have access to the outpatient clinic's schedule and be able to identify potentially eligible patients a priori so as to review medical records and identify potential patients. The diagnostic enrollment criterion includes a Doppler resting ankle-brachial index (ABI) ≤0.9026 or a significant drop in post-exercise ankle pressure of ≥20 mmHg. Patients will be asked to participate upon first visiting the PAD clinic, before treatment is started. Study coordinators at each center will obtain informed consent and perform the baseline interview at the outpatient clinic.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 21 years * New or recent exacerbation of exertional leg symptoms * Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg Exclusion Criteria: * Non-compressible ankle-brachial index (≥1.30) * Critical limb ischemia * Lower-limb endovascular or surgical vascular procedure in past year * Not speaking either English or Spanish * Hearing impaired * Unable to provide written informed consent * Currently a prisoner
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Miriam Hospital
Providence, Rhode Island, 02904, United States
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Ochsner Health System
New Orleans, Louisiana, 70121, United States
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
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Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
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Truman Medical Center
Kansas City, Missouri, 64108, United States
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Yale University
New Haven, Connecticut, 06520, United States
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