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

Primary Purpose

Diabetic Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bluedrop Monitoring Service (BMS)
Sponsored by
Bluedrop Medical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot focused on measuring Diabetic Foot Ulcer (DFU), Remote monitoring, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Male or female patients 18 years or older. Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit. History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening. 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) Patient has signed up for and provided or will provide consent to review of medical records available via the Pluto platform. Access to internet service at the site of device use or willing to use a 4G router provided by the Sponsor Access to cell phone on which they can receive study communications 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 English speaking Exclusion Criteria: Patients with active foot ulcers or other open foot lesions Weight, when fully clothed, of greater than 150 kg Active Charcot arthropathy defined as the phase where the foot is undergoing collapse Active foot infection or gangrene 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 Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicates adequate perfusion and qualifies for the study End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renal replacement therapy) Known pregnancy at the time of enrollment.* 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 Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days. Unable to identify and/or return to a usual care provider for foot care for the duration of the study Unable or unwilling to be enrolled in the Pluto unified medical records system 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.

Sites / Locations

  • Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Use of Bluedrop Monitoring Service

Standard of care

Arm Description

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.

Participants continue with routine foot care as recommended by their doctor

Outcomes

Primary Outcome Measures

Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)
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

Secondary Outcome Measures

Participant engagement rates in the BMS
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)
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
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

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Bluedrop Medical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT06053047
Brief Title
Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration
Acronym
MASTER
Official Title
Remote Use of Thermovisual Monitoring to Reduce the RAte of Re-Ulceration in PatientS at Risk of RecurrenT Diabetic Foot UlcERs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bluedrop Medical Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 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 BMS or not in addition to their otherwise usual care. Participants assigned to use of the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetic Foot Ulcer (DFU), Remote monitoring, Telemedicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of Bluedrop Monitoring Service
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants continue with routine foot care as recommended by their doctor
Intervention Type
Device
Intervention Name(s)
Bluedrop Monitoring Service (BMS)
Intervention Description
Remote use of ThermoVisual monitoring
Primary Outcome Measure Information:
Title
Relative risk reduction in the incidence of new Diabetic Foot Ulcers (DFUs)
Description
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Participant engagement rates in the BMS
Description
Defined as the percentage of participants whose average weekly adherence exceeds 3 days per week
Time Frame
Up to 12 months
Title
Relative risk reduction in the severity of new Diabetic Foot Ulcers (DFUs)
Description
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
Time Frame
Up to 12 months
Title
Relative risk reduction in resource utilization
Description
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
Time Frame
Up to 12 months
Other Pre-specified Outcome Measures:
Title
Improvement in participant-reported neuropathy-specific quality of life measures
Description
Survey-ascertained (improvement, better overall score) participant-reported neuropathy-specific quality of life measures
Time Frame
Up to 12 months
Title
Healthcare Provider acceptance of BMS
Description
Survey-ascertained healthcare provider acceptance of BMS in the management of patients with prior DFU
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Male or female patients 18 years or older. Diagnosis of type 1 or type 2 diabetes mellitus more than 3 months prior to the Screening Visit. History of healed diabetic foot ulcer(s), present for at least 2 weeks and healed within 2-24 months prior to screening. 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) Patient has signed up for and provided or will provide consent to review of medical records available via the Pluto platform. Access to internet service at the site of device use or willing to use a 4G router provided by the Sponsor Access to cell phone on which they can receive study communications 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 English speaking Exclusion Criteria: Patients with active foot ulcers or other open foot lesions Weight, when fully clothed, of greater than 150 kg Active Charcot arthropathy defined as the phase where the foot is undergoing collapse Active foot infection or gangrene 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 Critical limb ischemia as evidenced by rest pain. NOTE: a healed ulcer indicates adequate perfusion and qualifies for the study End-stage kidney disease (estimated GFR <15 mL/min/1.73 m2, and/or receiving renal replacement therapy) Known pregnancy at the time of enrollment.* 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 Any travel plans expected to result in an interruption of BMS use for greater than 30 consecutive days. Unable to identify and/or return to a usual care provider for foot care for the duration of the study Unable or unwilling to be enrolled in the Pluto unified medical records system 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefany Olague
Phone
9196680302
Email
smalltrials-CRC@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Green, MD
Organizational Affiliation
Duke UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefany Olage

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

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