A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease

NCT05335161 | Completed Phase 1 Results

• 1 other identifier: IRB-2022-375
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed pilot study is to evaluate the feasibility of a new leg heat therapy system treatment for patients with lower extremity PAD. The new system is comprised of leg-length water circulating pads surrounded by a separate pneumatic compression outer garment that compresses the pads against the skin for efficient heat transfer. The new leg garment is easily closed with a zipper. The air chambers automatically adjust the amount of air inflation enabling use of the garment independent of patient leg size. Six patients with PAD will be asked to complete daily (90 min/day) home-based leg HT for 12 weeks using the newly developed system. The primary study outcome is the change from baseline in walking performance on the 6-minute walk test at the 12-week follow-up. Secondary outcomes include plantar flexion power, as assessed using isokinetic dynamometry, sit-to-stand muscle power and perceived quality of life.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

heat therapy; peripheral artery disease

Outcome Measures

Primary Outcomes (1)

• Change in Six-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.

  Baseline to 12-week follow-up

Secondary Outcomes (4)

• Change in Walking Impairment Questionnaire Score

  Baseline to 12-week follow-up

• Device Usability Using the System Usability Scale

  Baseline to 12-week follow-up

• Change in Triceps Surae Peak Torque

  Baseline to 12-week follow-up

• Change in the Five Times Sit to Stand Test

  Baseline to 12-week follow-up

Study Arms (1)

Home-based leg heat therapy

EXPERIMENTAL

Patients will be provided with the Aquilo heat therapy device and will be instructed on how to operate the equipment. The device will be used in accordance to the manufacturers recommendations. Patients will be asked to apply the therapy daily in the home setting for 12 week (90 min/day, 7 days/week).

Device: Home-based leg heat therapy

Interventions

Home-based leg heat therapy DEVICE

The Aquilo system consists of a garment that contains an inner water-circulating pad that is compressed by air bladders. The volume of air inflating the air bladders is pressure-controlled so the garment automatically adjusts to the shape and size of all legs. The touch screen console contains pre-programmed settings for ease of use. After baseline characteristics are established, patients will be provided with the Aquilo device and will be instructed on how to operate the equipment and how to rapidly remove the system if the alarm sounds or if they have any unusual feeling. Patients in both groups will also receive a logbook to record their sessions. Patients will undergo daily home-based leg HT (90 min/day, 7 days/week) for 12 weeks. Water at 42ºC will be perfused through the water-circulating garment for 90 min, with the goal of increasing skin temperature in the calf to \~37ºC.

Also known as: Aquilo Sports

Home-based leg heat therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 60 years or older
• 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.

You may not qualify if:

• Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
• Prior 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)
• Unable to fit into water-circulating trousers
• A Mini-Mental Status Examination score \<23
• Impaired thermal sensation in the leg
• Age lower than 60 yrs

Sponsors & Collaborators

• Purdue University: lead
• Aquilo Sports: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Hyperthermia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Results Point of Contact

• Title: Bruno Tesini Roseguini
• Organization: Purdue University

brosegui@purdue.edu

7654962612

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Six patients with PAD will be asked to complete daily (90 min/day) home-based leg HT for 12 weeks using the newly developed system. Outcomes will be measured at baseline and at 12-week follow-up.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: May 30, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)