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Leg Heat Therapy for Peripheral Arterial Disease
Study Summary
This trial will evaluate the effects of leg heat therapy on lower-extremity functioning and quality of life in patients with PAD. 106 patients will be randomized to either leg HT or a sham intervention. Outcomes will be monitored for 12 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have had a foot or leg amputation.I have severe leg pain at rest or wounds that won't heal due to poor blood flow.I use a walking aid that is not a cane.My leg circulation test shows poor blood flow.My kidney function is severely reduced.I can't have an MRI due to certain medical devices or conditions.My BMI is 35 or higher.I cannot fit into water-circulating trousers.Your Mini-Mental Status Examination score is less than 23.I am older than 60 years.You are not able to exercise because of health issues other than leg pain, like heart problems, arthritis, or severe lung disease.I had surgery on my legs or for bone issues in the last 3 months.You have trouble feeling hot or cold in your leg.My cancer is currently active.
- Group 1: Heat therapy
- Group 2: Sham Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What detrimental effects does Heat therapy pose to individuals?
"Our assessment of Heat therapy's safety is 3 out of 3, as the trial has reached Phase three and there is ample evidence for both its efficacy and safety."
Are there still vacancies in this research trial for participants?
"This clinical trial, posted on November 11th 2022, is actively seeking participants. It was last revised on February 27th 2023 according to information on clinicaltrials.gov."
Is there a predetermined quota of participants for this research endeavor?
"Affirmative. The clinicaltrials.gov website reveals that this research is still open for enrollment, having been posted on November 11th 2022 and most recently updated in February 27th 2023. 106 patients are required to participate at a single site."
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