NCT00105755

Dermal Thermometry and Self-Care of High Risk Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Foot ulcers remain the most common reason for hospital admission among veterans with diabetes. Healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. Previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer.

Detailed description

Background: Foot ulcers remain the most common reason for hospital admission among veterans with diabetes. Healing and preventing these wounds should be a high priority for clinicians treating these high-risk patients. Previous work by the investigators has suggested that diabetic foot ulcers are preceded by inflammation, which can potentially be detected with a thermometer. Objectives: The purpose of this project is to evaluate the utility of a novel personal dermal thermometry system to empower patients and caregivers and thereby reduce the risk for lower extremity ulceration and amputation in veterans at high risk for these complications. Methods: In this randomized clinical trial, 384 patients are being enrolled and assigned to either standard of care (SC) or SC plus a personal dermal thermometer (DT) to evaluate and log their plantar skin temperatures. All patients are given access to a 24 hour "hot foot line" to call for immediate access to care if they identify a hot spot (DT group) or a site of concern on standard self-evaluation (SC). All patients are assigned a sophisticated computerized activity monitor, which allows investigators access to time and magnitude of activity, downloaded at regular patient visits. Status: Project work is complete

Conditions

• Diabetes Mellitus
• Ulcer
• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DEVICE	personal dermal thermometer (DT)
DEVICE	Device

Timeline

• Start date: 2003-01-01
• Completion: 2006-02-01
• First posted: 2005-03-17
• Last updated: 2015-04-07

Locations

1 site across 1 country: United States