Passive Stretching in Peripheral Arterial Disease Patients

NCT06420752 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 232-JC-230.2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.

Conditions

Peripheral Arterial Disease; Walking, Difficulty; Inflammation

Keywords

Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  6-minute walking distance will be assessed prior to an at various time points during the 12-week study

  12-14 weeks

Secondary Outcomes (2)

• Inflammatory markers

  12-14 weeks

• Vascular function

  12-14 weeks

Study Arms (2)

Functional Walking capacity

EXPERIMENTAL

Passive stretching of the calf muscles 5 days per week for 12-weeks

Device: Calf Plantar flexion; Dietary Supplement: Dietary nitrate

Inflammation

EXPERIMENTAL

Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation

Device: Calf Plantar flexion; Dietary Supplement: Dietary nitrate

Interventions

Calf Plantar flexion DEVICE

Daily passive calf stretching

Functional Walking capacity; Inflammation

Dietary nitrate DIETARY_SUPPLEMENT

Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

Functional Walking capacity; Inflammation

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle-brachial index of 0.90 or less Stable condition for at least 3 months

You may not qualify if:

• Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker

Sponsors & Collaborators

• University of Wisconsin, La Crosse: lead

Study Sites (1)

University of Wisconsin La Crosse

La Crosse, Wisconsin, 54650, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Mobility Limitation; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacob T Caldwell, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob T Caldwell, Ph.D.

CONTACT

608-785-8684; jcaldwell@uwlax.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind placebo controlled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Raw data will be available after two years post data collection to allow for publication and only available for one year after data collection is complete.
• Access Criteria: Researchers.

Locations

US (1)