A Predictive Technology for Prevention of Diabetic Foot Ulcers

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Alert for temperature delta

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Foot & Ankle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of diabetes
• ambulatory
• smart device

Exclusion Criteria:

• non-ambulatory
• no smart device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: DAPS Health LLC
• Investigators: Principal Investigator: Mark Sussman, Dr., DAPS Health LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: DFU
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 20204536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All temperature data analysis (Alerts and disposition) based on patient history
• IPD Sharing Time Frame: Within 6 months of completion of study
• IPD Sharing Access Criteria: not yet determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No