Dermal Thermometry and Self-Care of High Risk Diabetic Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus Ulcer Diabetic Polyneuropathy |
Device: personal dermal thermometer (DT) Device: ? |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Dermal Thermometry and Self-Care of High Risk Diabetic Patients |
- 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. [ Designated as safety issue: No ]
- Improve quality of life. Health Related Quality of Life (change over 18 months) [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2003 |
| Study Completion Date: | February 2006 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1 | Device: personal dermal thermometer (DT) Device: ? |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00105755 History of Changes |
| Other Study ID Numbers: | IIR 20-059 |
| Study First Received: | March 16, 2005 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Activity Cycles Amputation Prevention Temperature |
Additional relevant MeSH terms:
|
Diabetes Mellitus Ulcer Polyneuropathies Diabetic Neuropathies Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pathologic Processes Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications |
ClinicalTrials.gov processed this record on May 21, 2013