Passive Calf Stretching Therapy in Peripheral Artery Disease

Last updated: July 28, 2025
Sponsor: Penn State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intermittent Claudication

Peripheral Arterial Disease (Pad)

Thrombosis

Treatment

Passive calf muscle stretching device

Clinical Study ID

NCT06041880
00022960
  • Ages 40-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of PAD

  • Stable condition (PAD symptoms) for at least 3 months

  • Age 40-85

  • Men and women who are not pregnant or nursing

Exclusion

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 tothe ankle, Achilles tendon, or feet

  • History of rheumatoid arthritis or other degenerative joint disease

  • Major medical illness treatment during the prior 12 months

  • Uncontrolled hypertension

  • Uncontrolled diabetes

  • Inability to walk on a treadmill at a slow pace (1.0 mile/hour)

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Passive calf muscle stretching device
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
July 31, 2027

Study Description

Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.

Connect with a study center

  • Penn State University

    University Park, Pennsylvania 16802
    United States

    Active - Recruiting

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