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Could a daily leg warming session improve walking for PAD patients?

NCT ID NCT07653243

Symptom relief Sponsor: Aquilo Sports, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether applying heat to the legs for 90 minutes each day at home can improve walking distance and leg function in adults over 50 with peripheral artery disease (PAD). Participants are randomly assigned to receive either active heat therapy or a sham (low-heat) version for 12 weeks. The main goal is to see if the heat therapy group walks farther in a six-minute test compared to the sham group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lower-extremity heat therapy device
What this could lead to
If effective, daily heat therapy could become a simple home-based option to improve walking ability and quality of life for people with peripheral artery disease.
What could go wrong
This is a small early-stage trial with only 40 participants, so results may not apply broadly. The sham group also receives some heat, which could reduce the apparent benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PAD Pad - peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Methodist Hospital

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.