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A Predictive Technology for Prevention of Diabetic Foot Ulcers

D

DAPS Health

Status

Completed

Conditions

Diabetic Foot Ulcer

Treatments

Device: Alert for temperature delta

Study type

Interventional

Funder types

Other

Identifiers

NCT04769115
20204536

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of diabetes
  • ambulatory
  • smart device

Exclusion criteria

  • non-ambulatory
  • no smart device

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Response to Alerts
Other group
Description:
Monitor patients daily for response to temperature changes and provide referral to doctor as needed
Treatment:
Device: Alert for temperature delta

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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