Status:
COMPLETED
TempTouch IR Thermometry & Diabetic Patient Self-Care
Lead Sponsor:
Diabetica Solutions Inc.
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Polyneuropathy
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a...
Detailed Description
SIGNIFICANCE \& RATIONALE FOR PROPOSED PROJECT Foot problems are the most common complication in diabetics leading to hospitalization.1-5 Approximately one quarter of all hospital days for persons wit...
Eligibility Criteria
Inclusion
- diagnosis of diabetes by WHO criteria
- ability to provide informed consent
- 18-80 years of age
Exclusion
- patients with open ulcers or open amputation sites
- active Charcot arthropathy
- severe peripheral vascular disease
- active foot infection
- dementia -impaired cognitive function-
- history of drug or alcohol abuse within one year of the study
- other conditions based on the PI's clinical judgment
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00289497
Start Date
June 1 2000
End Date
July 1 2003
Last Update
February 9 2006
Active Locations (3)
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1
Steven R Beito, DPM
New Braunfels, Texas, United States, 78130
2
Robert Wunderlich, DPM
San Antonio, Texas, United States, 78212
3
8800 Village Drive, Suite 202
San Antonio, Texas, United States, 78217