๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-28

Passive Calf Stretching Therapy in Peripheral Artery Disease (NCT06041880)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Penn State University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are: 1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health. 2. To determine if daily calf muscle stretching at home improves walking performance. Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (16 items).

Location: Penn State University โ€” University Park, Pennsylvania

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene)
  • Any condition other than PAD that limits the ability to walk
  • Major surgery or lower extremity revascularization surgery in the past 6 months
  • Myocardial infarction within past 6 months or unstable angina
  • Severe lung disease (on supplemental oxygen or frequently use rescue inhalers)
  • Participants with non-compressible vessels (ABI \> 1.40)
  • Habitual exercise (30 minutes of continuous activity on 3 or more days per week)
  • Current tobacco smoker or use of nicotine-containing products
  • Pregnant or nursing women
  • History or ankle reconstruction or surgery Recent history (\<1 year) of injuries to the ankle, Achilles tendon, or feet
  • History of rheumatoid arthritis or other degenerative joint disease

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Penn State University โ€” University Park, Pennsylvania

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—