Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
Diabetic Foot Ulcer
About this trial
This is an interventional other trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active foot ulceration or open amputation sites
- An ulcer that has deemed to have healed within the 2 months prior to entry into the study
- Weight, when fully clothed, of greater than 150kg.
- Active Charcot neuro-osteoarthropathy
- Active foot infection
- Any history of lower limb amputation
- Significant Peripheral Arterial Disease (PAD) defined as history of revascularisation or absence of foot pulses
- 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
Sites / Locations
- Merlin Park University Hospital
- Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Other
Open Arm Study - All participants
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).