Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
NCT ID:
NCT05335161
Group ID:
EG000
Title:
Home-based Leg Heat Therapy
Description:
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).
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.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
6
Other Number Affected:
0
Other Number At Risk:
6
Study:
NCT05335161
Results Section:
NCT05335161
Adverse Events Module:
NCT05335161