Peripheral Arterial Disease Trial, Recruiting NCT03845036 Sponsor: University of Oklahoma Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT03845036
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a history of claudication (leg pain or cramping that occurs during walking or physical activity due to reduced blood flow).
  • People who have been diagnosed with peripheral artery disease (PAD), confirmed by at least one of the following: a resting ankle-brachial index (ABI) score below 0.90 (a test comparing blood pressure in the ankle and arm); a significant drop in ABI after a heel-rise exercise test in people who had a normal resting score; or a past history of a procedure to restore blood flow in the leg arteries.

Who may not be able to join:

  • People who do not have PAD, determined when all three of the following apply: a normal resting ABI score, no significant drop in ABI after a heel-rise exercise test, and no history of a leg artery procedure.
  • People whose blood vessels cannot be accurately measured using the standard ABI test due to hardened (non-compressible) arteries, indicated by an ABI score above 1.40.
  • People who have leg pain at rest caused by PAD (rather than only during activity).
  • People who have open wounds, sores, or tissue damage on the legs or feet caused by PAD.
  • People who started taking cilostazol or pentoxifylline (medications used to treat leg pain from poor circulation) within the three months before joining the trial.
  • People who had a procedure to restore blood flow in a leg artery within one month before joining the trial.
  • People who currently have active cancer.
  • People who have end-stage kidney disease (the most severe stage of chronic kidney disease, known as stage 5).
  • People who have a medical condition that would make exercise unsafe according to the American College of Sports Medicine guidelines (confirm with trial site).
  • People who show signs of significant cognitive difficulties, based on a standard memory and thinking test score below 24.
  • People who are unable to complete all the required baseline tests within a three-week period.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Andrew Gardner, Ph.D., Professor, Department of Medicine, Cardiology

Phone: 405-271-4742

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Oklahoma
Registry
ClinicalTrials.gov
Start date
16 September 2024
Est. completion
31 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Peak Walking Time; Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov