Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

NCT06053047 | Terminated FDA Device

• 1 other identifier: BMS CP002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic Foot Ulcer (DFU); Remote monitoring; Telemedicine

Outcome Measures

Primary Outcomes (1)

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

  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

  Up to 12 months

Secondary Outcomes (3)

• Participant engagement rates in the Bluedrop Monitoring System (BMS)

  Up to 12 months

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

  Up to 12 months

• Relative risk reduction in resource utilization

  Up to 12 months

Other Outcomes (2)

• Improvement in participant-reported neuropathy-specific quality of life measures

  Up to 12 months

• Healthcare Provider acceptance of Bluedrop Monitoring System (BMS)

  Up to 12 months

Study Arms (2)

Use of Bluedrop Monitoring Service

EXPERIMENTAL

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.

Device: Bluedrop Monitoring Service (BMS)

Standard of care

NO INTERVENTION

Participants continue with routine foot care as recommended by their doctor

Interventions

Bluedrop Monitoring Service (BMS) DEVICE

Remote use of ThermoVisual monitoring

Use of Bluedrop Monitoring Service

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bluedrop Medical Limited: lead

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

Location

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

• Jennifer Green, MD

  Duke UMC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 25, 2023
• Study Start: January 22, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)