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Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00105755
Enrollment
400
Registered
2005-03-17
Start date
2003-01-31
Completion date
2006-02-28
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Polyneuropathy, Ulcer

Keywords

Activity Cycles, Amputation, Prevention, Temperature

Brief 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

Interventions

DEVICEpersonal dermal thermometer (DT)
DEVICEDevice

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

vibration perception threshold needs to be greater than 25, palpable pulse, Over 18 years of age Has Diabetes and Neuropathy

Exclusion criteria

No ulcers. Unable to walk without assistance of wheelchair or crutches

Design outcomes

Primary

MeasureTime frame
Reduce the risk for lower extremity ulceration and amputation in veterans at high risk for these complications.; Incidence of diabetic foot ulcers over 18 months. Incidence of foot infections over 18 months. Incidence of Charcot fractures.

Secondary

MeasureTime frame
Improve quality of life. Health Related Quality of Life (change over 18 months)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026