Dermal Thermometry and Self-Care of High Risk Diabetic Patients

NCT00105755 | Completed

• 1 other identifier: IIR 20-059
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Ulcer; Diabetic Polyneuropathy

Keywords

Activity Cycles; Amputation; Prevention; Temperature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Study Arms (1)

Arm 1

OTHER

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

Interventions

personal dermal thermometer (DT) DEVICE

Arm 1

Device DEVICE

Arm 1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Georgia, 85723, United States

Location

Related Publications (2)

• 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.

  PMID: 15277427 RESULT

• 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.

  PMID: 18060924 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Ulcer; Diabetic Neuropathies

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Brent Nixon, DPM MBA BA

  Southern Arizona VA Health Care System, Tucson, AZ

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2005
• First Posted: March 17, 2005
• Study Start: January 1, 2003
• Study Completion: February 1, 2006
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)