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RecruitingNCT06041880Updated Oct 2, 2026

Passive Calf Stretching Therapy in Peripheral Artery Disease

An interventional study of Passive calf muscle stretching device in Peripheral Artery Disease and Claudication, Intermittent, sponsored by Penn State University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Primary conditionIntermittent ClaudicationRegistry: Peripheral Arterial DiseaseReclassifiedWhy we changed it
Registry
Peripheral Arterial Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Intermittent Claudication
Why
  1. The study's listed conditions name Intermittent Claudication, a narrower term within Peripheral Arterial Disease.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Penn State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Updated Oct 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Peripheral Artery Disease
  • Claudication, Intermittent

Browse trials for

Keywords

  • Endothelial dysfunction
03

In context

Intermittent Claudication Reclassified

309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.

This study's planned enrollment of 24 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.

Browse Intermittent Claudication studies →

Lead sponsor

Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    4-weeks of passive calf stretching for 30 minutes 5 days a week

    A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle.

    Device: Passive calf muscle stretching device

  • No intervention
    4-weeks of no-stretching

    No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks.

Interventions

  • DevicePassive calf muscle stretching device

    Modified night splints will be used to passive stretch the calf muscle.

    Also known as: Plantar fasciitis night splints

06

What researchers measure

Primary outcomes

  1. 6-minute walk test distance

    Submaximal exercise test used to assess aerobic capacity and endurance

    Time frame: 6-12 minutes

  2. Muscle to tendon ratio

    The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound

    Time frame: 45 minutes

  3. Endothelial function

    Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg.

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jul 2026→Jun 2027
Oct 2, 2026
Study completion
Jul 2027→Dec 2027
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Jul 2026→Jun 2027
    Study completion Jul 2027→Dec 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06041880
Collaborators
American Heart Association
Responsible party
David N. Proctor, PhD (Principal Investigator, Penn State University) — Principal investigator
First posted
Sep 18, 2023
Start date
Apr 1, 2024
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

David N Proctor, Ph.D.
Contact
dnp3@psu.edu
814-571-5234
Jocelyn M Delgado, B.S.
Contact
jmd956@psu.edu
408-679-8390

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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