Passive Calf Stretching Therapy in Peripheral Artery Disease

NCT06041880 | Recruiting FDA Device

• 1 other identifier: 00022960
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
2. 2.To determine if daily calf muscle stretching at home improves walking performance.

Conditions

Peripheral Artery Disease; Claudication, Intermittent

Keywords

Endothelial dysfunction

Outcome Measures

Primary Outcomes (3)

• 6-minute walk test distance

  Submaximal exercise test used to assess aerobic capacity and endurance

  6-12 minutes

• Muscle to tendon ratio

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

  45 minutes

• Endothelial function

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

  30 minutes

Study Arms (2)

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

EXPERIMENTAL

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

Device: Passive calf muscle stretching device

4-weeks of no-stretching

NO INTERVENTION

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

Interventions

Passive calf muscle stretching device DEVICE

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

Also known as: Plantar fasciitis night splints

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

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of PAD
• Stable condition (PAD symptoms) for at least 3 months
• Age 40-85
• Men and women who are not pregnant or nursing

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penn State University: lead
• American Heart Association: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David N Proctor, Ph.D.

CONTACT

814-571-5234; dnp3@psu.edu

Jocelyn M Delgado, B.S.

CONTACT

408-679-8390; jmd956@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)