Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:

Dermal Thermometry and Self-Care of High Risk Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105755
• Other study ID #: IIR 20-059
• Status: Completed
• Phase: N/A
• First received: March 16, 2005
• Last updated: April 6, 2015
• Start date: January 2003
• Est. completion date: February 2006

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies
• Ulcer

Intervention

Device:
• personal dermal thermometer (DT)

• Device

Locations

Country	Name	City	State
United States	Southern Arizona VA Health Care System, Tucson, AZ	Tucson	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Armstrong DG, Lavery LA, Holtz-Neiderer K, Mohler MJ, Wendel CS, Nixon BP, Boulton AJ. Variability in activity may precede diabetic foot ulceration. Diabetes Care. 2004 Aug;27(8):1980-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Secondary	Improve quality of life. Health Related Quality of Life (change over 18 months)			No