NCT06420752 Passive Stretching in Peripheral Arterial Disease Patients
| NCT ID | NCT06420752 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Wisconsin, La Crosse |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2024-05-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Ankle-brachial index of 0.90 or less Stable condition for at least 3 months Exclusion Criteria: 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
Contact & Investigator
Jacob T Caldwell, Ph.D.
PRINCIPAL INVESTIGATOR
Assistant Professor
Frequently Asked Questions
Who can join the NCT06420752 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06420752 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06420752 currently recruiting?
Yes, NCT06420752 is actively recruiting participants. Contact the research team at jcaldwell@uwlax.edu for enrollment information.
Where is the NCT06420752 trial being conducted?
This trial is being conducted at La Crosse, United States.
Who is sponsoring the NCT06420752 clinical trial?
NCT06420752 is sponsored by University of Wisconsin, La Crosse. The principal investigator is Jacob T Caldwell, Ph.D. at Assistant Professor. The trial plans to enroll 64 participants.