Peripheral Artery DiseaseNCT05465070
Leg Heat Therapy in Peripheral Artery Disease
A study testing Leg heat therapy in people with Peripheral Artery Disease, run by Indiana University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Leg heat therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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. 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.
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
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Janet Klein, RN, 317-962-0287, jswklein@iupui.edu
About this study
Official title: Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
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).
Read the detailed description
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).
- Conditions
- Peripheral Artery Disease
- Being tested
- Leg heat therapy, Sham Control
- Keywords
- heat therapy, peripheral artery disease, walking performance, muscle strength
- Medical subject headings
- Peripheral Arterial Disease, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg heat therapyDevice
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.
Sham ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Heat therapy | Experimental | 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. Receives: Device: Leg heat therapy |
| Sham Control | Active comparator | 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. Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3-month follow-up
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start7 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Raghu Motaganahalli, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465070
- Sponsor's protocol ID
- 13615
- Other IDs
- 1R01AG073634-01A1
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT05465070
- Acronym / sponsor ID
- 13615
- Conditions
- Peripheral Artery Disease
- Keywords
- heat therapy, peripheral artery disease, walking performance, muscle strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institute on Aging (NIA)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jul 2022 (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.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat therapy | Experimental | Device: Leg heat therapyPatients 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. |
| Sham Control | Active comparator | Device: Sham ControlPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Leg heat therapyA 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. | Device | Heat therapy |
| Sham ControlA 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. | Device | Sham Control |
Primary outcome
Change in 6-minute walk distance
Time frame: Baseline to 3-month follow-up
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.
10 secondary outcomes
Change in Walking Impairment Questionnaire (WIQ) score
Time frame: Baseline to 3-month follow-up
Change in Short-Form (SF)-36 Questionnaire score
Time frame: Baseline to 3-month follow-up
Change in Short Physical Performance Battery (SPPB) score
Time frame: Baseline to 3-month follow-up
Change in handgrip strength
Time frame: Baseline to 3-month follow-up
Change in systolic blood pressure
Time frame: Baseline to 3-month follow-up
Change in diastolic blood pressure
Time frame: Baseline to 3-month follow-up
Change in triceps surae volume
Time frame: Baseline to 3-month follow-up
Change in triceps surae intramuscular fat content
Time frame: Baseline to 3-month follow-up
Change in the time constant for phosphocreatine recovery after dynamic exercise
Time frame: Baseline to 3-month follow-up
Change in maximal plantar flexor strength
Time frame: Baseline to 3-month follow-up
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 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg heat therapy in people with Peripheral Artery Disease, run by Indiana University 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 2 inclusion and 12 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 17 Aug 2026. 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.
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 Kimmy Marshall, RN (317-274-7440, marshki@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (time frame: Baseline to 3-month follow-up). 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 17 Aug 2026.