BMS001 - Pilot Study - Remote Thermovisual Monitoring

  • Research type

    Research Study

  • Full title

    A Pilot Study to Investigate the Use of Remote Thermovisual Monitoring in Patients with a Previous Diabetic Foot Ulcer, during the COVID-19 pandemic.

  • IRAS ID

    298364

  • Contact name

    Chris Murphy

  • Contact email

    chris@bluedropmedical.com

  • Sponsor organisation

    Bluedrop Medical Ltd

  • Clinicaltrials.gov Identifier

    NCT05039645

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    0 years, 5 months, 5 days

  • Research summary

    The goal of the clinical trial is to investigate adherence to, and effects of, the Bluedrop Monitoring System (BMS) in high-risk patients with at least one previous diabetic foot ulcer (DFU).

    The BMS is a remote thermovisual monitoring system, which allows the condition of the soles of the feet to be remotely monitored for thermal and visual signs of inflammation, both of which may signal the onset of certain conditions, such as diabetic foot ulcers.

    It is comprised of the Delta Foot Scanner (DFS) device and its accompanying Sentinel Review Interface (SRI) software.

    The Covid-19 pandemic has driven the need for remote patient care where possible.  Although this is challenging for people with foot ulcers, prevention is the key. Remote thermovisual monitoring might help reduce recurrent foot ulcers and therefore the number of necessary hospital visits which always puts the patient at increased risk of Covid infection.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    21/NW/0190

  • Date of REC Opinion

    4 Mar 2022

  • REC opinion

    Further Information Favourable Opinion