An interventional study of Leg heat therapy and Sham Control in Peripheral Artery Disease, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
The lack of accessible therapies amenable for application in the home setting is a major obstacle for treating patients who suffer from lower-extremity peripheral artery disease (PAD). The investigators will determine whether unsupervised, home-based leg heat therapy (HT) improves walking performance compared to a sham intervention. Leg HT will be applied using water-circulating trousers coupled with a water pump and a water heater. Patients will be randomized into one of two groups: those receiving HT (n=53) or those receiving a sham treatment (n=53).The water heater and pump given to participants in the HT group will be adjusted to circulate water at 42ºC through the trousers. In the sham group, water at 33ºC will be circulated through the trousers. Participants will be asked to apply the therapy daily for 90 min for 3 consecutive months. Outcomes will be assessed at baseline, at the completion of the intervention (end of week 12) and at a follow-up visit, 12 weeks after the end of the intervention (week 24). The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, which combines performance in walking speed, standing balance, and repeated chair rises, changes in handgrip strength, perceived quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 106 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
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Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
As this study involves MR imaging, patients that have to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Device: Leg heat therapy
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Device: Sham Control
A sous vide heating immersion circulator heats up the water inside the water tank to 42ºC. A water pump circulates temperature-regulated water through the trousers.
A sous vide heating immersion circulator heats up the water inside the water tank to 33ºC. A water pump circulates temperature-regulated water through the trousers.
Change in 6-minute walk distance
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.
Time frame: Baseline to 3-month follow-up
Change in Walking Impairment Questionnaire (WIQ) score
This disease-specific questionnaire assess the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. Higher scores are reflective of better community-based walking ability. The investigators will determine whether leg heat therapy improves the WIQ score at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in Short-Form (SF)-36 Questionnaire score
Health-related quality of life (HRQOL) will be assessed using the short-form SF-36 questionnaire, which is composed of 8 subscales. Each subscale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The investigators will determine whether leg heat therapy improves the SF-36 score at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in Short Physical Performance Battery (SPPB) score
The SPPB combines data from the usual paced 4-m walking velocity, time to rise from a seated position 5 times, and standing balance. The timed results of the subtests will be converted to an ordinal scale ranging from 0 (worst performance) to 12 (best performance). The investigators will determine whether leg heat therapy improves the SPPB score at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in handgrip strength
The assessment of maximal handgrip strength will be will performed using a hand dynamometer. The investigators will determine whether leg heat therapy improves handgrip strength at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in systolic blood pressure
The systolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves systolic blood pressure at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in diastolic blood pressure
The diastolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves blood pressure at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in triceps surae volume
The volume of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy improves calf muscle volume at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in triceps surae intramuscular fat content
The intramuscular fat content of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy reduces intramuscular fat content at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in the time constant for phosphocreatine recovery after dynamic exercise
Magnetic resonance spectroscopy tuned to phosphorous (31PMRS) will be used to measure the time constant for PCr recovery (τ) after dynamic planar flexion exercise. The investigators will determine whether leg heat therapy reduces the time constant for PCr recovery at 3-month follow-up compared to the sham treatment.
Time frame: Baseline to 3-month follow-up
Change in maximal plantar flexor strength
The maximal voluntary contraction (MVC) strength of the plantar flexor muscles will be assessed using an MR-compatible ergometer (Trispect, Ergospect GmbH, Innsbruck, Austria), Participants will be asked to perform three 4-5 s plantar-flexor MVCs separated by a one-minute rest period. The MVC torque will be considered the highest peak torque value measured over the three trials.
Time frame: Baseline to 3-month follow-up
Plan to share: Undecided
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