NCT04072744: FOOT

Foot Oedema Observed Over Time Study

Completed Last updated 2 February 2023

What this trial tests

trial testing Heartfelt measurements in Heart Failure in 31 participants. Completed in 30 December 2022.

Timeline

11 December 2019

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Heartfelt Technologies
Status	Completed
Study type	OBSERVATIONAL
Enrollment	31
Start date	11 December 2019
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	5 locations across United Kingdom

Drugs / interventions tested

• Heartfelt measurements
• Connected weighing scales

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Edema Leg — all drugs for Edema Leg →

Sponsor

Heartfelt Technologies — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Edema Leg. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. An important part of discharge planning includes measures such as early follow up in order to prevent readmissions. The hallmark of heart failure is fluid retention and between 2009 and 2016, 43% to 50% of hospital admissions were associated with peripheral oedema. Therefore, early recognition of this and treatment of the congestion may prevent hospital admissions. In clinical trials, management strategies have included patient education, telemedicine and remote monitoring. The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker.

The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs. The volumes can then be calculated and thus, changes in amount of peripheral oedema can be estimated. In a laboratory study performed by the Heart Failure team at the Royal Brompton Hospital, there was good correlation between measurements made by Heartfelt and a water displacement method. The resolution was as good as 20mls.

By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Images are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. Personal identifiable data (participant name, address, age…) is stored on an encrypted hard drive, along with linkage information (device serial numbers) to associate the participant identifiable data with the data captured in the home. Therefore, data collection is not only secure but entirely passive, which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients.

Our hypothesis is that 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume.
   Chausiaux O, Williams G, Nieznański M, Bagdu A, et al · · 2021 · cited 7× · PMID 33880069 · DOI 10.2147/mder.s297713