Foot Oedema Observed Over Time Study

CompletedOBSERVATIONAL
Enrollment

31

Participants

Timeline

Start Date

December 11, 2019

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2022

Conditions
Heart FailureEdema Leg
Interventions
DEVICE

Heartfelt measurements

"The measurements taken using the Heartfelt device do not require contact with the participant. For the measurements to take place, the participant will simply walk in the field of view of the device. As the device(s) will have been installed at a location allowing the best view of where the participant goes in an out of bed, the participant is not expected to change anything to their routine.~The device can also take measurements in the dark, so if the participant walks in front of the device in the dark, this information will also be captured.~The Heartfelt device is a CE (European Conformity) marked product. Neither the participant, or the medical team will be able to see the data collected by the Heartfelt device during the study. They will be blinded to the data until each participant has completed the study. At that point they can choose to review the data from participant individually or wait until all the data from all participants is available."

DEVICE

Connected weighing scales

"The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records.~The participant will be able to see the weight readings on the weighing scales during the study.~The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link."

Trial Locations (5)

LU4 0DZ

Bedfordshire Hospitals NHS Foundation Trust, Luton

TS19 8PE

North Tees and Hartlepool Hospitals NHS Foundation Trust, Stockton-on-Tees

TQ27AA

Torbay and South Devon NHS Foundation Trust, Torquay

LE3 9QP

University Hospitals of Leicester NHS Trust, Leicester

NE29 8NH

Northumbria Healthcare NHS Foundation Trust, North Shields

Sponsors
All Listed Sponsors
collaborator

Torbay and South Devon NHS Foundation Trust

OTHER

lead

Heartfelt Technologies

INDUSTRY