Peripheral Arterial DiseasePhase 2NCT06420752
Passive Stretching in Peripheral Arterial Disease Patients
A Phase 2 study testing Calf Plantar flexion and Dietary nitrate in people with Peripheral Arterial Disease and Walking, Difficulty, run by University of Wisconsin, La Crosse at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease, Walking, Difficulty, Inflammation
- What is being tested?
- Calf Plantar flexion and Dietary nitrate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle-brachial index of 0.90 or less Stable condition for at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin La Crosse
La Crosse, Wisconsin, 54650
Jacob T Caldwell, Ph.D., 608-785-8684
About this study
Official title: Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease
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.
- Being tested
- Calf Plantar flexion, Dietary nitrate
- Keywords
- Cardiovascular
- Medical subject headings
- Peripheral Arterial Disease, Mobility Limitation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calf Plantar flexionDevice
Daily passive calf stretching
Dietary nitrateDietary supplement
Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching
| Study group | Role | What they receive |
|---|---|---|
| Functional Walking capacity | Experimental | Passive stretching of the calf muscles 5 days per week for 12-weeks Receives: 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 Receives: Device: Calf Plantar flexion; Dietary Supplement: Dietary nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
6-minute walking distance will be assessed prior to an at various time points during the 12-week study
Measured: 12-14 weeks
Secondary outcomes (2)
Inflammatory markers
Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.
Measured: 12-14 weeks
Vascular function
Large vessel (flow-mediated vasodilation) and small vessel (Near-infrared spectroscopy on the calf) will be measured prior to and at various time points during the 12-week study.
Measured: 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 May 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, La Crosse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Caldwell, University of Wisconsin, La Crosse
- Investigators
- Jacob T Caldwell, Ph.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420752
- Sponsor's protocol ID
- 232-JC-230.2
- Status last verified
- Mar 2025
- First submitted
- 14 May 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study datasets will be submitted to a generalist repository (Aging Research Bio Bank or similar). This allows for individual-level data submission from clinical studies. This study will not generate genomics data and will not submit to the database of Genotypes and Phenotypes. To our understanding, the National Institutes of Aging repository is the only current general repository for aging related work
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06420752
- Acronym / sponsor ID
- 232-JC-230.2
- Keywords
- Cardiovascular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Wisconsin, La CrosseUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Walking capacity | Experimental | Device: Calf Plantar flexion, Dietary Supplement: Dietary nitratePassive stretching of the calf muscles 5 days per week for 12-weeks |
| Inflammation | Experimental | Device: Calf Plantar flexion, Dietary Supplement: Dietary nitrateBlood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ankle-brachial index of 0.90 or less Stable condition for at least 3 months
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calf Plantar flexionDaily passive calf stretching | Device | Functional Walking capacity, Inflammation |
| Dietary nitrateWeekday 140 ml dietary nitrate consumption two hours prior to passive stretching | Dietary supplement | Functional Walking capacity, Inflammation |
Primary outcome
Functional capacity
Time frame: 12-14 weeks
6-minute walking distance will be assessed prior to an at various time points during the 12-week study
2 secondary outcomes
Inflammatory markers
Time frame: 12-14 weeks
Vascular function
Time frame: 12-14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. The study datasets will be submitted to a generalist repository (Aging Research Bio Bank or similar). This allows for individual-level data submission from clinical studies. This study will not generate genomics data and will not submit to the database of Genotypes and Phenotypes. To our understanding, the National Institutes of Aging repository is the only current general repository for aging related work
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob T Caldwell, Ph.D. principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calf Plantar flexion and Dietary nitrate in people with Peripheral Arterial Disease and Walking, Difficulty, run by University of Wisconsin, La Crosse at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob T Caldwell, Ph.D. (608-785-8684, jcaldwell@uwlax.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 12-14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.