Phase 3 Peripheral Arterial Disease Trial, Recruiting NCT05132439 Sponsor: VA Office of Research and Development Condition: Peripheral Arterial Disease
Back to Peripheral Arterial Disease

Phase 3 Peripheral Arterial Disease Trial, Recruiting

NCT05132439
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:

  • You are a male or female Veteran between the ages of 36 and 88
  • You have symptoms of leg pain or cramping when walking (known as intermittent claudication)
  • You have been medically stable and receiving standard treatments for more than 3 months, such as cholesterol-lowering medication, blood thinners, blood pressure control, smoking cessation support, and physical activity advice (confirm with trial site if you are not on all of these)
  • You have been diagnosed with peripheral artery disease (reduced blood flow in the legs), confirmed by specific leg blood pressure or circulation tests done within the last 6 months
  • You are able to walk at least 50 meters (about 165 feet) in 6 minutes, and your leg pain starts before or at 400 meters, without using a walker (a cane is acceptable), tested within the last 6 months

Who may not be able to join:

  • You have Type 1 or Type 2 diabetes, or a recent blood sugar test showed a result of 6.5 or higher
  • You are currently taking or have taken the medication metformin in the last 6 months
  • You have another health condition (besides leg artery disease) that affects your ability to walk, such as chest pain, heart failure, a lung condition requiring oxygen, or active cancer treatment
  • You have had an amputation of part or all of either leg
  • You have severe leg artery disease causing non-healing wounds or pain at rest
  • You have a major surgery, hospital stay, or leg artery procedure planned within the next 12 months
  • You have had a major surgery or leg artery procedure within the 3 months before joining the trial
  • You are unable to complete quality-of-life questionnaires due to not speaking English or having dementia
  • You have significant kidney disease, including being on dialysis or having a low kidney function score (eGFR below 45) within the last 6 months
  • You have a procedure using contrast dye (like a CT scan with dye) planned within the next 6 months
  • You have current or past liver failure
  • You are currently pregnant or breastfeeding
  • You are unable to swallow whole (uncrushed) pills
  • The trial doctor believes joining the trial could put you at risk of harm

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 22 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: Edith I. Tzeng, MD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Phone: (412) 360-1657

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
1 March 2022
Est. completion
28 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximal Walking distance on the 6 minute walk test

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: 22 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