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

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

May 30, 2023

Primary Completion Date

February 7, 2024

Study Completion Date

February 7, 2024

Conditions
Peripheral Arterial DiseaseIntermittent Claudication
Interventions
DEVICE

Home-based leg heat therapy

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.

Trial Locations (1)

47907

Purdue University, West Lafayette

All Listed Sponsors
collaborator

Aquilo Sports

UNKNOWN

lead

Purdue University

OTHER

NCT05335161 - A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease | Biotech Hunter | Biotech Hunter