A Predictive Technology for Prevention of Diabetic Foot Ulcers

NCT04769115 | Completed

• 1 other identifier: 20204536
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Keywords

DFU

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Response to Alerts

OTHER

Monitor patients daily for response to temperature changes and provide referral to doctor as needed

Device: Alert for temperature delta

Interventions

Alert for temperature delta DEVICE

If alert for potential complications refer to appropriate specialist

Response to Alerts

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of diabetes
• ambulatory
• smart device

You may not qualify if:

• non-ambulatory
• no smart device

Sponsors & Collaborators

• DAPS Health LLC: lead

Study Sites (1)

Annapolis Foot & Ankle

Annapolis, Maryland, 21401, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Mark Sussman, Dr.

  DAPS Health LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diabetics who have no history of lower extremity (LEX) complications Diabetics who a history of LEX complications

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 24, 2021
• Study Start: February 24, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of completion of study
• Access Criteria: not yet determined

Locations

US (1)