Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer

NCT05039645 | Completed

• 1 other identifier: BMS CP001
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Patient Adherence

  Patient adherence, tracked throughout duration of study, as measured through the number of device uses in each week, and the average number of device uses over the whole study.

  3 months

Secondary Outcomes (5)

• Clinic reported utility of thermovisual data for remote analysis and remote intervention - Number of scans in each Likert response category

  3 months

• Clinic reported utility of thermovisual data for remote analysis and remote intervention - Percentage of scans in each Likert response category

  3 months

• Level of agreement between in-person visual assessment and remote assessment.

  3 months

• Patient reported device usability

  3 months

• DFU Incidence rates and severities

  3 months

Study Arms (1)

Open Arm Study - All participants

OTHER

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).

Behavioral: Patient specific, clinician determined Intervention

Interventions

Patient specific, clinician determined Intervention BEHAVIORAL

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).

Open Arm Study - All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bluedrop Medical Limited: lead

Study Sites (2)

Merlin Park University Hospital

Galway, Ireland

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 15504999 BACKGROUND

• 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.

  PMID: 17192326 BACKGROUND

• 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.

  PMID: 18060924 BACKGROUND

• 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.

  PMID: 28614678 BACKGROUND

• 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.

  PMID: 12027925 BACKGROUND

• 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.

  PMID: 15229307 BACKGROUND

• 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.

  PMID: 31004370 BACKGROUND

• 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.

  PMID: 26334001 BACKGROUND

• 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.

  PMID: 26452160 BACKGROUND

• 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.

  PMID: 29559450 BACKGROUND

• 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.

  PMID: 28637356 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Andrew Boulton, PhD

  Prof. of Medicine, University of Manchester & Consultant Physician, Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

• Caroline McIntosh, PhD

  Podiatric Medicine School of Health Sciences Áras Moyola, NUI Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: September 9, 2021
• Study Start: March 31, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IE (1)