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Passive Stretching for Peripheral Arterial Disease
Phase 2
Recruiting
Led By Jacob T Caldwell, Ph.D.
Research Sponsored by University of Wisconsin, La Crosse
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Critical limb ischemia, amputation, or leg pain at rest
Heart Failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-14 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how passive stretching of calf muscles can help improve walking ability in patients with Peripheral Artery Disease (PAD). The study will track inflammatory markers and cardiovascular changes over 12 weeks of
Who is the study for?
This trial is for individuals with Peripheral Arterial Disease (PAD), which causes leg pain and difficulty walking due to poor blood flow. Participants should be interested in exploring non-drug treatments like stretching and dietary changes to improve their condition.
What is being tested?
The study tests if passive calf muscle stretching, possibly combined with dietary nitrate supplements, can increase nitric oxide levels, reduce inflammation, and enhance walking ability in PAD patients over a period of 12 weeks.
What are the potential side effects?
Since the interventions involve dietary changes and physical therapy techniques like stretching, side effects may include muscle soreness or gastrointestinal discomfort from the nitrates.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe leg pain, am at risk of losing a limb, or have had an amputation.
Select...
I have heart failure.
Select...
I haven't had major surgery or leg artery surgery in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-14 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional capacity
Secondary study objectives
Inflammatory markers
Vascular function
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: InflammationExperimental Treatment2 Interventions
Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation
Group II: Functional Walking capacityExperimental Treatment2 Interventions
Passive stretching of the calf muscles 5 days per week for 12-weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary nitrate
2010
N/A
~70
Find a Location
Who is running the clinical trial?
University of Wisconsin, La CrosseLead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
Jacob T Caldwell, Ph.D.Principal InvestigatorAssistant Professor