Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease

NCT07653243 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: AQUILO-LEHT-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

PAD; PAD - Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Peak plantar flexor and knee extensor power

  12 weeks

• Plantar flexor and knee extensor resistance to fatigue

  12 weeks

• Short Physical Performance Battery (SPPB) score

  12 weeks

• Walking Impairment Questionnaire (WIQ)

  12 weeks

Study Arms (2)

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.

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.

Device: Sham Lower-Extremity Heat Therapy

Interventions

Lower-Extremity Heat Therapy DEVICE

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.

Active Lower-Extremity Heat Therapy

Sham Lower-Extremity Heat Therapy DEVICE

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.

Sham Lower-Extremity Heat Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aquilo Sports, LLC: lead
• Indiana University: collaborator
• Purdue University: collaborator

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Raghu Motaganahalli, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raghu Motaganahalli, MD

CONTACT

317-962-2300; rmotagan@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)