Dermal Thermometry and Self-Care of High Risk Diabetic Patients

• ClinicalTrials.gov Identifier: NCT00105755
• Recruitment Status: Completed
• First Posted: March 17, 2005
• Last Update Posted: April 7, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: March 16, 2005
• First Posted Date: March 17, 2005
• Last Update Posted Date: April 7, 2015
• Study Start Date: January 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 12, 2005): 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.
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: August 2, 2005): Improve quality of life. Health Related Quality of Life (change over 18 months)
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dermal Thermometry and Self-Care of High Risk Diabetic Patients
• Official Title: Dermal Thermometry and Self-Care of High Risk Diabetic Patients
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Diabetes Mellitus
• Ulcer
• Diabetic Polyneuropathy

Intervention

• Device: personal dermal thermometer (DT)
• Device: Device

Study Arms

Arm 1

Interventions:

• Device: personal dermal thermometer (DT)
• Device: Device

Publications *

• 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. doi: 10.2337/diacare.27.8.1980.
• Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028. Erratum In: Am J Med. 2008 Dec;121(12). doi: 10.1016/j.amjmed.2008.09.029.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: June 23, 2005): 400
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2006
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00105755
• Other Study ID Numbers: IIR 20-059
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Original Responsible Party: Not Provided
• Current Study Sponsor: US Department of Veterans Affairs
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brent Nixon, DPM MBA BA; Southern Arizona VA Health Care System, Tucson, AZ

• PRS Account: VA Office of Research and Development
• Verification Date: April 2015