Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
Key facts
- Who runs it
- Bluedrop Medical Limited
- Where
- Ireland and United Kingdom2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 31 people enrolled
- Started
- 31 Mar 2022
- Ended
- 12 Dec 2023
- Type of study
- Interventional
- Treatments tested
- Patient specific, clinician determined Intervention
- Record updated
- 3 January 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Diagnosis of diabetes mellitus types 1 or 2
- Aged 18 years or older
- Have loss of protective sensation based on the presence of peripheral neuropathy (Vibration Perception Threshold (VPT) ≥ 25V on either foot)
- Have a recent history of a DFU (i.e. an ulcer, defined as cutaneous erosion through the dermis on the foot) which was present for at least 2 weeks and has healed within 2-18 months before entry into the study
- Ability to provide informed consent
- Able to walk independently for 10m or more
- The patient has foot care from a podiatrist or is willing to undergo foot care by a podiatrist
- Access to a mobile phone so able to receive text notifications, or access to a landline to receive telephone call notifications
Who cannot take part
- An ulcer that has deemed to have healed within the 2 months prior to entry into the study
- Concomitant severe physical or mental condition(s) that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to use DFS, without having a carer who can perform the temperature measurements
- Active foot infection
- Any history of lower limb amputation
- Significant Peripheral Arterial Disease (PAD) defined as history of revascularisation or absence of foot pulses
- Active foot ulceration or open amputation sites
- Weight, when fully clothed, of greater than 150kg
- Active Charcot neuro-osteoarthropathy
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The group in the trial
- Open Arm Study - All participantsOther group
Study is open arm with no blinding or randomisation. Patients will receive standard care including frequent clinical visits, education, and preventative foot care/podiatry as required. Patients will also be given a DFS thermovisual scanner device. Patients will be instructed to use the DFS on a daily basis, at home, to record thermovisual data about the soles of their feet. Data collected from the DFS device will be transmitted to a remote, cloud-based server for daily review using the SRI software. If a temperature difference of \>2.2°C between similar points on the left and right feet is identified for 2 consecutive scans, or visible signs of skin damage are observed, the site will be notified and sent a report containing the findings. Once notified the site will contact the patient by telephone and determine the best course of action based on standard practices (e.g. offloading, attending an appointment).
Treatment: Patient specific, clinician determined Intervention
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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.
- Record updated
- 3 January 2024