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Remote Monitoring for Diabetic Foot (MASTER Trial)

N/A

Recruiting

Led By Jennifer Green, MD

Research Sponsored by Bluedrop Medical Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

MASTER Trial Summary

This trial will look at how well the BMS can help prevent diabetic foot ulcers in people with diabetes.

Who is the study for?

This trial is for English-speaking adults over 18 with type 1 or type 2 diabetes who've had a diabetic foot ulcer that healed within the last 2-24 months. They must have internet, a cell phone, and a healthcare provider using compatible electronic health records. Excluded are those with severe kidney disease, current foot ulcers or infections, certain limb issues, history of substance abuse affecting study reliability, or plans to be away for more than 30 days.Check my eligibility

What is being tested?

The Bluedrop Monitoring System (BMS) is being tested to see if it can prevent foot ulcers in people with diabetes. Participants will use BMS daily at home alongside their usual care and answer regular surveys about their foot health over the course of one year.See study design

What are the potential side effects?

There may not be direct side effects from using the BMS as it's a monitoring device; however, discomfort or inconvenience from daily use could occur. Any unexpected reactions related to its use should be reported.

MASTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My medical records show I have nerve damage in my hands or feet.

MASTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Participant engagement rates in the Bluedrop Monitoring System (BMS)

Relative risk reduction in resource utilization

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

Other outcome measures

Healthcare Provider acceptance of Bluedrop Monitoring System (BMS)

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

MASTER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Use of Bluedrop Monitoring ServiceExperimental Treatment1 Intervention

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.

Group II: Standard of careActive Control1 Intervention

Participants continue with routine foot care as recommended by their doctor

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Bluedrop Medical LimitedLead Sponsor

1 Previous Clinical Trials

31 Total Patients Enrolled

1 Trials studying Diabetic Foot

31 Patients Enrolled for Diabetic Foot

Jennifer Green, MDPrincipal InvestigatorDuke UMC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently recruiting participants for this research?

"Based on the information found on clinicaltrials.gov, this scientific exploration is not presently seeking out participants. The trial was first published in September 1st 2023 and saw its last revision on 12th of that same month; however, there are currently 145 other studies recruiting patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration

2024. "Remote Monitoring of the Diabetic Foot to Prevent Re-Ulceration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053047.