Trial Outcomes & Findings for A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease (NCT NCT05335161)

Device feasibility, safety, and usability were evaluated in an open-label, single-arm pilot study performed at Purdue University in West Lafayette, Indiana. Participants were provided the prototype HT device and were asked to apply the therapy daily (90 minutes, 7 days/week) for 12 weeks. The first participant was enrolled on May 30, 2023. The final follow-up occurred on February 7, 2024.

Participants attended two baseline laboratory visits. No run-in or wash-out period was used, and no participants were excluded between enrollment and assignment.

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

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.

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 indicate better walking ability (i.e., better outcome). Lower scores indicate greater walking impairment (i.e., worse outcome)

Scores range from 0 to 100; \> 70 represents acceptable usability.

Torque assessments of the plantar flexors will be performed using an isokinetic dynamometer. Participants will be asked to perform 3 maximal contractions.

Participants were asked to sit in a chair with arms folded across their chest and stand five times consecutively as quickly as possible. The time it took to complete five chair rises was measured.