The FOOT Study
Research type
Research Study
Full title
Foot Oedema Observed over Time
IRAS ID
265988
Contact name
Oriane Chausiaux
Contact email
Sponsor organisation
Heartfelt Technologies Ltd
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The aim of the study is to assess if the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that, on average, the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales.
During this study, the readings will not be reviewed until the end of the study so that normal care is not affected or biased by the data collected.
The ultimate goal is to assess how good the Heartfelt device can be at detecting peripheral oedema (swollen ankles) in the home. Peripheral oedema is the swelling of the body's extremities (most commonly feet and lower legs). It can be a very good indicator of some medical conditions such as heart failure.
Swollen ankles is caused by a build-up of fluid (oedema); it may be better in the morning and get worse later in the day.
Identifying when the body retains excess fluid may help with treatment and hospitalisation prevention.
Water tablets, or diuretics, help reduce blood pressure and remove excess fluid as they make the kidneys excrete more water and salt. Swollen ankles are a common indication of excess fluid: patients are advised to speak to their doctor if this keeps happening to them. And in most cases, patients are able to do this and report the symptoms in time for their doctors to change their medications. However, not all patients manage to report those symptoms on time.
The medical device (Heartfelt) that we are studying is ultimately aimed at those patients who are not able to follow a regimen of medication and monitoring of their own health to report issues to their doctors. The concept of the device is that it is installed in the patients’ bedroom and scans their feet from a distance, as they walk around or get in and out of bed, to measure the volume of their ankle. In future, this data would then be sent to the patient's medical team who will determine if the patient requires a medical appointment to review their medication, and health status.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0252
Date of REC Opinion
20 Sep 2019
REC opinion
Further Information Favourable Opinion