A Predictive Technology for Prevention of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.

Detailed Description
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Diabetes has become a major health issue in the United States and globally, particularly among older populations. There are currently 400 million diabetics worldwide, with 30 million diagnosed diabetics living in the US. 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.

Official Title
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A Predictive Technology for Prevention of Diabetic Foot Ulcers, and in Real Time, Identifying Diabetic Patients Who Experience Lower Extremity Trauma and Vascular Obstruction Utilizing the Science of Temperature (Inflammation) Trending

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Alert for temperature delta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of diabetes ambulatory smart device Exclusion Criteria: non-ambulatory no smart device

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Diabetics who have no history of lower extremity (LEX) complications Diabetics who a history of LEX complications
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Response to Alerts<br>Monitor patients daily for response to temperature changes and provide referral to doctor as needed | Device: Alert for temperature delta<br>* If alert for potential complications refer to appropriate specialist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicting diabetic foot complications | Monitor patients daily for inflammatory responses to trauma to avoid complications. This examines multiple plantar points on each foot and does a contralateral comparison to ensure there is no inflammatory response equal or greater than 4 degrees F between each pair. When this occurs over multiple days, we alert the patient to contact their physician. The temperature readings will be recorded using the DAPS Health system comprised of the Exergen DermaTemp 2000 FootScanner, DAPS Health Application and backend analysis. | Evaluate results daily and compare previous results to analyze multiple days with a contralateral delta of 4 degrees or more. This will be a running comparison over the three months of the trial. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU