Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration (MASTER)

• ClinicalTrials.gov Identifier: NCT06053047
• Recruitment Status: Recruiting
• First Posted: September 25, 2023
• Last Update Posted: February 2, 2024
• Sponsor: Bluedrop Medical Limited
• Information provided by (Responsible Party): Bluedrop Medical Limited

Tracking Information

• First Submitted Date: September 12, 2023
• First Posted Date: September 25, 2023
• Last Update Posted Date: February 2, 2024
• Actual Study Start Date: January 22, 2024
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2023)

Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]

Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers where a higher score is a worse outcome <min score of 0 and max score of 3>) in participants assigned to use of the BMS compared to those not assigned to use of the BMS

Original Primary Outcome Measures (submitted: September 12, 2023)

Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]

Relative risk reduction in the incidence of new DFU (Wound Stage 2 or 3 as defined by University of Texas Staging System for Diabetic Foot Ulcers) in participants assigned to use of the BMS compared to those not assigned to use of the BMS

Current Secondary Outcome Measures (submitted: December 6, 2023)

• Participant engagement rates in the Bluedrop Monitoring System (BMS) [ Time Frame: Up to 12 months ]
  Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
• Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]
  Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) in participants assigned to use of the BMS compared to those not assigned to use of the BMS
• Relative risk reduction in resource utilization [ Time Frame: Up to 12 months ]
  Both all-cause and related to diabetic foot complications, in participants assigned to use of the Bluedrop Monitoring System (BMS) compared to those not assigned to use of the Bluedrop Monitoring System (BMS)

Original Secondary Outcome Measures (submitted: September 12, 2023)

• Participant engagement rates in the BMS [ Time Frame: Up to 12 months ]
  Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
• Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs) [ Time Frame: Up to 12 months ]
  Relative risk reduction in the severity of new DFU in participants assigned to use of the BMS compared to those not assigned to use of the BMS
• Relative risk reduction in resource utilization [ Time Frame: Up to 12 months ]
  Both all-cause and related to diabetic foot complications, in participants assigned to use of the BMS compared to those not assigned to use of the BMS

Current Other Pre-specified Outcome Measures (submitted: December 6, 2023)

• Improvement in participant-reported neuropathy-specific quality of life measures [ Time Frame: Up to 12 months ]
  Survey-ascertained (improvement, better overall score) participant-reported neuropathy-specific quality of life measures
• Healthcare Provider acceptance of Bluedrop Monitoring System (BMS) [ Time Frame: Up to 12 months ]
  Survey-ascertained healthcare provider acceptance of Bluedrop Monitoring System (BMS) in the management of patients with prior Diabetic Foot Ulcer (DFU)

Original Other Pre-specified Outcome Measures (submitted: September 12, 2023)

• Improvement in participant-reported neuropathy-specific quality of life measures [ Time Frame: Up to 12 months ]
  Survey-ascertained (improvement, better overall score) participant-reported neuropathy-specific quality of life measures
• Healthcare Provider acceptance of BMS [ Time Frame: Up to 12 months ]
  Survey-ascertained healthcare provider acceptance of BMS in the management of patients with prior DFU

Descriptive Information

• Brief Title: Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
• Official Title: Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs

Brief Summary

The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.

All Participants in this study will continue with their normal foot care and complete surveys with questions about their foot health every three months.

Participants selected to receive the Bluedrop Monitoring System (BMS) will place it in their home and stand on it once a day for 12 months. Participants will also need to answer questions about their general foot health and, if using the system, their experience using the device and monitoring service.

Detailed Description

This is a siteless study, which is planned to enroll approximately 200 patients with diabetes mellitus and a foot ulcer which has healed within 2-24 months prior to screening. The study will be organized and conducted via a central coordinating center at the Duke Clinical Research Institute. Potentially eligible patients within the state of North Carolina will be contacted about the study and if willing, will provide consent to participation remotely, including use of the Pluto Health''s unified medical records platform. Participants will not attend study sites, as all study visits will take place virtually and/or by telephone contact from the coordinating center and the primary study outcomes will be ascertained by review of health records via the Pluto system.

All enrolled participants will be randomized to use of the Bluedrop Monitoring System (BMS) or not in addition to their otherwise usual care. Participants assigned to use of the Bluedrop Monitoring System (BMS) will be provided the Delta Foot Scanner device with monitoring system and will be instructed in daily device use by Bluedrop personnel.

Participants will continue to receive all other usual care during the study period, and the patient's other care may be adjusted as considered clinically appropriate by the usual care provider(s).

After study enrollment, study visits will take place at 3, 6, 9 and 12 months. These visits will include participant surveys including assessment of neuropathy-specific quality of life, and review of health records via the Pluto Health platform by the study Principal Investigator (PI) to identify the occurrence of foot injury or ulcer and any associated medical or surgical care.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Diabetic Foot

Intervention

Device: Bluedrop Monitoring Service (BMS)

Remote use of ThermoVisual monitoring

Study Arms

• Experimental: Use of Bluedrop Monitoring Service

  The BMS is made up of the Delta Foot Scanner (DFS) device, its accompanying Sentinel Review Interface (SRI) software and a Bluedrop virtual monitoring service.

  The DFS is intended to be used for 30 seconds, once per day, by a person in their home. It is important that while using the device that the participant continues with their routine foot care as recommended by their doctor.

  Intervention: Device: Bluedrop Monitoring Service (BMS)
• No Intervention: Standard of care
  Participants continue with routine foot care as recommended by their doctor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 12, 2023): 190
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing consent prior to any study-specific procedures.
2. Male or female patients 18 years or older.
3. Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit.
4. History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening.
5. Confirmation of presence of peripheral neuropathy with loss of protective sensation (documented in medical records or certain ICD-10 codes for care of patients with diabetes and loss of protective sensation)
6. Patient has signed up for and provided or will provide consent to review of medical records available via the Pluto platform.
7. Access to internet service at the site of device use or willing to use a 4G router provided by the Sponsor
8. Access to cell phone on which they can receive study communications
9. Has a healthcare provider who is confirmed to be their point of contact for foot care or injuries and this HCP uses an EHR that is compatible with Pluto
10. English speaking

Exclusion Criteria:

1. Patients with active foot ulcers or other open foot lesions
2. Weight, when fully clothed, of greater than 150 kg
3. Active Charcot arthropathy defined as the phase where the foot is undergoing collapse
4. Active foot infection or gangrene
5. Any history of major or minor lower limb amputation of more than 3 toes. NOTE: the hallux toe must be present on both feet to be eligible
6. Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicates adequate perfusion and qualifies for the study
7. End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renal replacement therapy)
8. Known pregnancy at the time of enrollment.*
9. Any mental health disorder, psychiatric disorder, or alcohol or drug abuse history such that, in the opinion of the investigator, the patient is unreliable as a study participant
10. Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days.
11. Unable to identify and/or return to a usual care provider for foot care for the duration of the study
12. Unable or unwilling to be enrolled in the Pluto unified medical records system

13. Other issue that, at the discretion of the PI, renders the participant ineligible for participation. This includes inability to use the BMS for at least 3 days per week.

    • Participants who become pregnant during the study will not be removed. Pregnancy will be noted in their mobile application profile and their participation in the study will be closely monitored.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Stefany Olague; 9196680302; smalltrials-CRC@duke.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06053047
• Other Study ID Numbers: BMS CP002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bluedrop Medical Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Bluedrop Medical Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jennifer Green, MD; Duke UMC

• PRS Account: Bluedrop Medical Limited
• Verification Date: February 2024