A Predictive Technology for Prevention of Diabetic Foot Ulcers
NCT ID: NCT04769115
Last Updated: 2021-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2021-02-24
2021-07-01
Brief Summary
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Detailed Description
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The standard of care today in treating complications of diabetes is a reactive one: doctors often wait for a problem to occur and then treat it. This waiting approach results in high medical expenses and an increase in pain for patients.
This study is testing a predictive technology system (investigational bluetooth-enabled thermometer and mobile app) to see if it can identify potential foot complications before the damage becomes irreversible. The thermometer being used in this study is the Exergen DermaTemp (DT) Thermometer. Participants will check the temperature of each foot daily for a period of three months. These results will sync directly from the thermometer to the mobile app.
Patients are notified when temperature levels indicate a potential complication that may lead to a developing foot ulcer. The study doctor is available to determine if any trauma or vascular obstruction has occurred and will follow up with the participant.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Response to Alerts
Monitor patients daily for response to temperature changes and provide referral to doctor as needed
Alert for temperature delta
If alert for potential complications refer to appropriate specialist
Interventions
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Alert for temperature delta
If alert for potential complications refer to appropriate specialist
Eligibility Criteria
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Inclusion Criteria
* ambulatory
* smart device
Exclusion Criteria
* no smart device
35 Years
ALL
No
Sponsors
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DAPS Health LLC
OTHER
Responsible Party
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Principal Investigators
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Mark Sussman, Dr.
Role: PRINCIPAL_INVESTIGATOR
DAPS Health LLC
Locations
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Annapolis Foot & Ankle
Annapolis, Maryland, United States
Countries
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Other Identifiers
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20204536
Identifier Type: -
Identifier Source: org_study_id
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