Phase 3 Peripheral Arterial Disease Trial, Recruiting NCT04794530 Sponsor: Northwestern University Condition: Peripheral Arterial Disease
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Phase 3 Peripheral Arterial Disease Trial, Recruiting

NCT04794530
Recruiting Phase 3

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 aged 55 or older
  • People diagnosed with peripheral artery disease (PAD), which the trial defines in one of three ways: a standard circulation test result (called an ABI) showing 0.90 or below; imaging or lab results showing a significant blockage or reduced blood flow to the legs; or a borderline circulation test result that drops noticeably after a heel-rise exercise test

Who may not be able to join:

  • People who have had an amputation of part or all of a leg
  • People with a severe form of PAD where blood flow to the limbs is critically reduced (confirm with trial site)
  • People who use a wheelchair full-time or need a walker to get around
  • People whose walking is limited by a condition other than PAD
  • People who currently have an ulcer (open sore) on the bottom of a foot
  • People who do not complete a required one-week trial preparation period
  • People who have major surgery, heart procedures, or leg artery procedures planned within the next eight months
  • People who have had major surgery, a heart procedure, a leg artery procedure, or a major heart event in the past three months
  • People with serious medical conditions, including lung disease requiring oxygen use during the day, Parkinson's disease, a life-threatening illness with a life expectancy under eight months, or cancer that required treatment in the past two years — though some exceptions may apply (confirm with trial site)
  • People who score below 23 on a standard memory and thinking assessment
  • People with a known allergy to the trial product
  • People who have taken cocoa supplements in the past three months, are unwilling to avoid cocoa flavanol supplements during the trial, or regularly eat dark chocolate (roughly more than 1.5 ounces more than three times per week)
  • People who do not speak English
  • People who have taken part in another clinical trial in the past three months — though exceptions may apply depending on the type of trial previously completed (confirm with trial site)
  • People whose vision problems affect their ability to walk
  • People whose walking distance on a standard six-minute walk test falls outside a specific range (under 500 feet or over 1,600 feet)
  • People who have taken part in a supervised treadmill exercise program in the past three months
  • People who cannot tolerate caffeine
  • People the trial investigators determine the trial would not be safe or suitable for, based on their medical judgement

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 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mary McDermott, MD, Northwestern University

Phone: 312-503-6419

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
Phase 3
Registry
ClinicalTrials.gov
Start date
19 November 2021
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Six-month change in six-minute walk distance

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: 13 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