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Passive Calf Stretching Therapy in Peripheral Artery Disease

Sponsor: Penn State University • ClinicalTrials.gov ID: NCT06041880

Registry updated: 2026-10-02

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Description

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.

Interventions

Passive calf muscle stretching device (Device)
Modified night splints will be used to passive stretch the calf muscle.

Eligibility criteria

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 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 * 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)

Conditions

Peripheral Artery Disease Claudication, Intermittent

Locations

Penn State University — University Park, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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