- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00500175
Novel Home Care Device for High-Risk Diabetic Patients (TempTouchRM)
Study Overview
Status
Intervention / Treatment
Detailed Description
The study's central hypothesis is that the TempTouchRM device will reduce the incidence of ulcers by providing an accurate, simple, and effective approach to monitor changes in foot temperatures. To study this hypothesis, the following specific aims are proposed:
Aim 1: To develop, validate and implement software and protocols for the following: (i) data acquisition and processing, and (ii) the physician-TempTouchRM communications interface. A state-of-the-art web interface will be developed to allow clinicians to view the stored data for their patients.
Aim 2: To evaluate the effectiveness of the TempTouchRM in reducing the incidence of diabetic foot ulcers among high-risk patients. Our hypothesis is that patients monitored with the TempTouchRM will have fewer foot ulcers and that the ulcers will be less severe. The 110 patient study will comprise two treatment arms: the standard therapy group and the enhanced therapy group The latter will receive standard care plus infrared temperature monitoring using the TempTouchRM daily for 12 months. Elevated temperatures will provide information to the physician that prevention practices should be initiated, such as off-loading, skin care, etc.
Aim 3: To determine the normal range of temperature variations for each individual foot for patients in the Enhanced Therapy and to correlate deviations from this range to the incidence of ulcers. Our previous studies have used the contralateral foot as the control to detect abnormal temperatures. We will investigate the hypothesis that with proper trending of normal foot temperatures, the individual foot can serve as its own control for predicting ulcers.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kevin R HIggins, DPM
- Phone Number: (210) 657-2644
- Email: higgins@xilas.com
Study Contact Backup
- Name: Ruben G Zamorano, MSW, MPH
- Phone Number: 119 (210) 692-1114
- Email: zamorano@xilas.com
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Recruiting
- Kevin R. Higgins, DPM
-
Contact:
- Ruben G Zamorano, MSW, MPH
- Phone Number: 119 210-692-1114
- Email: zamorano@xilas.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80 years of age.
Exclusion Criteria:
- 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, or other conditions based on the PI's clinical judgment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incident foot ulcers
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
temperature spikes on foot zones
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK061815
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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