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New treatment option for Peripheral Artery Disease
Official title Leg Heat Therapy in Peripheral Artery Disease
ClinicalTrials.gov ID: NCT05465070
What this study is testing
- What it's testing
- The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Men and women older than 50 years
- Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be...
You likely can't join if
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
- Prior foot or leg amputation
- Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
- Recent (\<3 months) lower-extremity revascularization or orthopedic surgery
- Use of walking aid other than a cane
- Active cancer
See the full eligibility criteria
- Men and women older than 50 years
- Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
- Prior foot or leg amputation
- Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
- Recent (\<3 months) lower-extremity revascularization or orthopedic surgery
- Use of walking aid other than a cane
- Active cancer
- Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
- Class 2 or 3 obesity (BMI ≥ 35 kg/m2)
- Unable to fit into water-circulating trousers
- A Mini-Mental Status Examination score \<23
- Impaired thermal sensation in the leg As this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.