Clinical trial NCT05039645: Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Bluedrop Medical Limited
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a single-arm, open-label, multicentre, pilot/feasibility study evaluating the adherence and usability of daily use of remote thermovisual monitoring alongside standard of care in patients with a previous DFU.
Primary purpose: OTHER

Brief 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.

Detailed description: Despite the introduction of preventative foot care guidelines DFUs have a high re-ulceration rate. In the first 12 months following healing, 30-50% will develop a subsequent DFU and by year 5 this rate increases to 70%. Temperature monitoring has been proposed as a way to reduce this re-ulceration rate but has not been widely adopted.

Based on the existing evidence groups such as the International Working Group on the Diabetic Foot (IWGDF) have recommended temperature monitoring for the prevention of recurrent foot ulcers.

Despite these recommendations the technique has not been widely adopted. This is likely due to a number of factors, but NICE, in their guidance document for the prevention and management of foot ulcers (NG19) states:

"While temperature foot monitoring was found to be the only effective form of augmented self-examination, the intervention tool was felt to be quite difficult to use and required a strongly motivated population to actually perform consistently and fill out the required log books".

Bluedrop Medical have developed a product which leverages the existing evidence on temperature monitoring but builds it into a device which also includes the ability to take photographic images, is easy to use, and can integrate well with the healthcare system.

The goal of the clinical trial is to demonstrate that patients will use the device consistently over the course of the study. It will also be used to determine the clinician reported utility of thermovisual data to conduct a remote assessment or remote intervention.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of diabetes mellitus types 1 or 2
2. Aged 18 years or older
3. Have loss of protective sensation based on the presence of peripheral neuropathy (Vibration Perception Threshold (VPT) ≥ 25V on either foot)
4. 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
5. Ability to provide informed consent
6. Able to walk independently for 10m or more
7. The patient has foot care from a podiatrist or is willing to undergo foot care by a podiatrist
8. Access to a mobile phone so able to receive text notifications, or access to a landline to receive telephone call notifications.

Exclusion Criteria:

1. Active foot ulceration or open amputation sites
2. An ulcer that has deemed to have healed within the 2 months prior to entry into the study
3. Weight, when fully clothed, of greater than 150kg.
4. Active Charcot neuro-osteoarthropathy
5. Active foot infection
6. Any history of lower limb amputation
7. Significant Peripheral Arterial Disease (PAD) defined as history of revascularisation or absence of foot pulses
8. 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

Primary outcomes:
measure: Patient Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Clinic reported utility of thermovisual data for remote analysis and remote intervention - Number of scans in each Likert response category
timeFrame: 3 months
measure: Clinic reported utility of thermovisual data for remote analysis and remote intervention - Percentage of scans in each Likert response category
timeFrame: 3 months
measure: Level of agreement between in-person visual assessment and remote assessment.
timeFrame: 3 months
measure: Patient reported device usability
timeFrame: 3 months
measure: DFU Incidence rates and severities
timeFrame: 3 months
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Merlin Park University Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Prof. of Medicine, University of Manchester & Consultant Physician, Manchester Royal Infirmary
name: Andrew Boulton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Podiatric Medicine School of Health Sciences Áras Moyola, NUI Galway
name: Caroline McIntosh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642.
citation: Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;30(1):14-20. doi: 10.2337/dc06-1600.
citation: Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028.
citation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
citation: Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N, Johnson KE, Ryder CH, Torkington R, Van Ross ER, Whalley AM, Widdows P, Williamson S, Boulton AJ; North-West Diabetes Foot Care Study. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med. 2002 May;19(5):377-84. doi: 10.1046/j.1464-5491.2002.00698.x.
citation: Boulton AJ, Kirsner RS, Vileikyte L. Clinical practice. Neuropathic diabetic foot ulcers. N Engl J Med. 2004 Jul 1;351(1):48-55. doi: 10.1056/NEJMcp032966. No abstract available.
citation: Kerr M, Barron E, Chadwick P, Evans T, Kong WM, Rayman G, Sutton-Smith M, Todd G, Young B, Jeffcoate WJ. The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med. 2019 Aug;36(8):995-1002. doi: 10.1111/dme.13973. Epub 2019 Jun 5.
citation: Bus SA, van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE; International Working Group on the Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:16-24. doi: 10.1002/dmrr.2696. No abstract available.
citation: Bus SA, van Netten JJ. A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:195-200. doi: 10.1002/dmrr.2738.
citation: Jeffcoate WJ, Vileikyte L, Boyko EJ, Armstrong DG, Boulton AJM. Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcers. Diabetes Care. 2018 Apr;41(4):645-652. doi: 10.2337/dc17-1836.
citation: Yap MH, Chatwin KE, Ng CC, Abbott CA, Bowling FL, Rajbhandari S, Boulton AJM, Reeves ND. A New Mobile Application for Standardizing Diabetic Foot Images. J Diabetes Sci Technol. 2018 Jan;12(1):169-173. doi: 10.1177/1932296817713761. Epub 2017 Jun 21.