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Diet and exercise may ease leg pain for PAD patients

NCT ID NCT03845036

Symptom relief Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining the DASH diet (a heart-healthy eating plan) with a home-based walking program can improve walking ability and quality of life in people with peripheral artery disease (PAD). PAD causes leg pain during walking due to narrowed arteries. The study will enroll 150 adults with PAD and follow them for 3 months to measure changes in walking time and physical function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. History of claudication, 2. Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest \< 0.90, or \> 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (\> 0.90), or history of peripheral revascularization. Exclusion Criteria: 1. absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest \> 0.90), \< 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization, 2. non-compressible vessels (ABI \> 1.40), 3. rest pain due to PAD (Fontaine stage III; Rutherford Grade II), 4. tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III), 5. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 6. peripheral revascularization within one month prior to investigation, 7. active cancer, 8. end stage renal disease defined as stage 5 chronic kidney disease, 9. medical conditions that are contraindicative for exercise according to the American College of Sports Medicine, 10. cognitive dysfunction (mini-mental state examination score \< 24), and 11. failure to complete the baseline tests within three weeks.

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Conditions

The condition(s) this trial relates to.

intermittent vascular claudication peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Claudication Peripheral artery disease

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • O'Donoghue Research Building, University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73117, United States

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