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Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

NCT06053047 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-17

No results posted yet for this study

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

Interventions

DEVICE

Bluedrop Monitoring Service (BMS)

Remote use of ThermoVisual monitoring

Sponsors & Collaborators

  • Bluedrop Medical Limited

    lead INDUSTRY

Principal Investigators

  • Jennifer Green, MD · Duke UMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2024-09-18
Completion
2024-09-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053047 on ClinicalTrials.gov