NCT06041880 · Penn State University
Passive Calf Stretching Therapy in Peripheral Artery Disease
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of PAD
- Stable condition (PAD symptoms) for at least 3 months
- 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)
Where
- University Park, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations