PADNCT07653243
Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease
A study testing Lower-Extremity Heat Therapy in people with PAD and PAD - Peripheral Arterial Disease, run by Aquilo Sports, LLC at 1 site in United States.
Trial summary
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- PAD, PAD - Peripheral Arterial Disease
- What is being tested?
- Lower-Extremity Heat Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jun 2029
- 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 of age
- Resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg
Who cannot join
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity
- Recent (<3 months) lower-extremity revascularization or orthopedic surgery
- Use of walking aid other than a cane
- Active treatment for cancer
Show all 9Show 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
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
Methodist Hospital
Indianapolis, Indiana, 46202
Raghu Motaganahalli, MD, 317-962-2300, rmotagan@iu.edu
About this study
Official title: A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease.
A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition.
The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Read the detailed description
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, exercise intolerance, and decreased quality of life. Reduced physical function in individuals with peripheral artery disease can limit daily activity and contribute to progressive mobility loss. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function, lower-extremity performance, blood pressure, and quality of life in adults with peripheral artery disease.
A total of 40 participants with peripheral artery disease will be enrolled and randomized to active lower-extremity heat therapy or sham therapy. Eligible participants will include men and women older than 45 years with a resting ankle-brachial index of less than 0.90 and greater than 0.40 in at least one leg. Participants will be excluded for conditions that may interfere with safe participation or outcome assessment, including critical limb ischemia, ischemic rest pain, ischemia-related non-healing wounds or tissue loss, prior amputation, major exercise-limiting comorbidity, recent lower-extremity revascularization or orthopedic surgery, use of a walking aid other than a cane, active treatment for cancer, severe chronic kidney disease, class 2 or 3 obesity, or inability to use the study treatment system as intended.
Participants will complete baseline study visits that include informed consent, resting ankle-brachial index measurement, familiarization with study procedures, and baseline assessment of walking function and lower-extremity performance. Baseline outcome measures will include the six-minute walk test, assessment of calf strength and fatigability using isokinetic dynamometry, the Short Physical Performance Battery, and blood pressure measurement.
After completion of baseline assessments, participants will be randomized to one of two study groups using a blocked randomization scheme stratified by sex. Participants assigned to the active therapy group will complete daily 90-minute home-based lower-extremity heat therapy sessions for 12 weeks. Participants assigned to the sham therapy group will complete the same treatment schedule using a lower-temperature sham condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy.
Outcome assessments will be repeated at week 6 and week 12. To evaluate chronic rather than acute responses to treatment, participants will be instructed to interrupt therapy 48 hours before follow-up outcome visits. The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
- Conditions
- PAD, PAD - Peripheral Arterial Disease
- Being tested
- Lower-Extremity Heat Therapy, Sham Lower-Extremity Heat Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower-Extremity Heat TherapyDevice
Participants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol.
Sham Lower-Extremity Heat TherapyDevice
Participants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy.
| Study group | Role | What they receive |
|---|---|---|
| Active Lower-Extremity Heat Therapy | Experimental | Participants assigned to this arm will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active therapy condition will use heated lower-extremity garments according to the study protocol. Receives: Device: Lower-Extremity Heat Therapy |
| Sham Lower-Extremity Heat Therapy | Sham comparator | Participants assigned to this arm will complete sham home-based lower-extremity therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments, with a lower-temperature condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy. Receives: Device: Sham Lower-Extremity Heat Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min. The primary outcome will be a change from baseline in the 6-minute walk distance over 12 weeks in the HT-treated group as compared to the sham treatment group.
Measured: 12 weeks
Secondary outcomes (4)
Peak plantar flexor and knee extensor power
Torque assessments of the plantar flexors and knee extensors of the most symptomatic leg or the leg with the lowest ABI will be performed using an isokinetic dynamometer. Each subject will be asked to perform 3 maximal contractions at angular velocities of 0, 1.57, 3.14, 4.71, and 6.28 rad/sec, with 2 min of rest between each set. Peak power will be calculated by multiplying the peak torque observed at each velocity by that velocity. A parabolic function will be used to determine the subject's maximal plantar flexor velocity (Vmax) and maximal power (P max). The change in peak power from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
Measured: 12 weeks
Plantar flexor and knee extensor resistance to fatigue
Participants will perform 50 consecutive maximal contractions of the plantar flexor and knee extensor muscles at an angular velocity of 3.14 rad/sec to determine their resistance to fatigue. The fatigue index will be defined as a % decrease in power from first 1/3 to last 1/3 of the test) during repeated contractions. The change in fatigue resistance from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
Measured: 12 weeks
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) (1). The change in the SPPB score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
Measured: 12 weeks
Walking Impairment Questionnaire (WIQ)
This disease-specific questionnaire assesses the ability of patients with PAD to walk defined distances and speeds and to climb stairs, with scores ranging from 0 to 100. The change in the WIQ score from baseline to 12 weeks will be compared between the HT-treated group and the sham treatment group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PADStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aquilo Sports, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University, Purdue University
- Responsible party
- Sponsor
- Investigators
- Raghu Motaganahalli, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653243
- Sponsor's protocol ID
- AQUILO-LEHT-001
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The plan for sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be determined after review of the final protocol, informed consent language, institutional requirements, sponsor requirements, participant privacy protections, and applicable regulatory and funding requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-Controlled Trial of Home-Based Lower-Extremity Heat Therapy in Adults With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07653243
- Acronym / sponsor ID
- AQUILO-LEHT-001
- Conditions
- PAD, PAD - Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aquilo Sports, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University, Purdue University
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jun 2026 (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.
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease.
A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition.
The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Detailed description
Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, exercise intolerance, and decreased quality of life. Reduced physical function in individuals with peripheral artery disease can limit daily activity and contribute to progressive mobility loss. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function, lower-extremity performance, blood pressure, and quality of life in adults with peripheral artery disease.
A total of 40 participants with peripheral artery disease will be enrolled and randomized to active lower-extremity heat therapy or sham therapy. Eligible participants will include men and women older than 45 years with a resting ankle-brachial index of less than 0.90 and greater than 0.40 in at least one leg. Participants will be excluded for conditions that may interfere with safe participation or outcome assessment, including critical limb ischemia, ischemic rest pain, ischemia-related non-healing wounds or tissue loss, prior amputation, major exercise-limiting comorbidity, recent lower-extremity revascularization or orthopedic surgery, use of a walking aid other than a cane, active treatment for cancer, severe chronic kidney disease, class 2 or 3 obesity, or inability to use the study treatment system as intended.
Participants will complete baseline study visits that include informed consent, resting ankle-brachial index measurement, familiarization with study procedures, and baseline assessment of walking function and lower-extremity performance. Baseline outcome measures will include the six-minute walk test, assessment of calf strength and fatigability using isokinetic dynamometry, the Short Physical Performance Battery, and blood pressure measurement.
After completion of baseline assessments, participants will be randomized to one of two study groups using a blocked randomization scheme stratified by sex. Participants assigned to the active therapy group will complete daily 90-minute home-based lower-extremity heat therapy sessions for 12 weeks. Participants assigned to the sham therapy group will complete the same treatment schedule using a lower-temperature sham condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy.
Outcome assessments will be repeated at week 6 and week 12. To evaluate chronic rather than acute responses to treatment, participants will be instructed to interrupt therapy 48 hours before follow-up outcome visits. The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Lower-Extremity Heat Therapy | Experimental | Device: Lower-Extremity Heat TherapyParticipants assigned to this arm will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active therapy condition will use heated lower-extremity garments according to the study protocol. |
| Sham Lower-Extremity Heat Therapy | Sham comparator | Device: Sham Lower-Extremity Heat TherapyParticipants assigned to this arm will complete sham home-based lower-extremity therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments, with a lower-temperature condition designed to preserve participant blinding while minimizing the expected physiological effects of active heat therapy. |
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 of age
- Resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg
Key exclusion criteria (9 listed)
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss
- Prior amputation
- Exercise-limiting comorbidity
- 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 |
|---|---|---|
| Lower-Extremity Heat TherapyParticipants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol. | Device | Active Lower-Extremity Heat Therapy |
| Sham Lower-Extremity Heat TherapyParticipants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy. | Device | Sham Lower-Extremity Heat Therapy |
Primary outcome
6-minute walk distance
Time frame: 12 weeks
Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min. The primary outcome will be a change from baseline in the 6-minute walk distance over 12 weeks in the HT-treated group as compared to the sham treatment group.
4 secondary outcomes
Peak plantar flexor and knee extensor power
Time frame: 12 weeks
Plantar flexor and knee extensor resistance to fatigue
Time frame: 12 weeks
Short Physical Performance Battery (SPPB) score
Time frame: 12 weeks
Walking Impairment Questionnaire (WIQ)
Time frame: 12 weeks
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 Jun 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing de-identified individual participant data has not yet been finalized. Any future data sharing will be determined after review of the final protocol, informed consent language, institutional requirements, sponsor requirements, participant privacy protections, and applicable regulatory and funding requirements.
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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.
Raghu Motaganahalli, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower-Extremity Heat Therapy in people with PAD and PAD - Peripheral Arterial Disease, run by Aquilo Sports, LLC 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 9 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: opening soon, as of the sponsor's last update on 17 Jun 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. Some participants in this study may receive a placebo. 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 Raghu Motaganahalli, MD (317-962-2300, rmotagan@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (time frame: 12 weeks). 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 Jun 2026.