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Novel Home Care Device for High-Risk Diabetic Patients (TempTouchRM)

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ClinicalTrials.gov Identifier: NCT00500175
Recruitment Status : Unknown
Verified July 2007 by Diabetica Solutions Inc..
Recruitment status was:  Recruiting
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
National Institutes of Health (NIH)
Information provided by:
Diabetica Solutions Inc.

Brief Summary:
More than half of all lower extremity amputations are in persons with diabetes. These patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they frequently do not protect their feet from repetitive shear stress or traumatic episodes and ulceration often ensues. We have previously shown that the temperature profile of the plantar aspects of the foot provides a reliable warning of tissue injury and can be effectively used as a preventive modality. In this study we propose to further develop and clinically test a novel infrared-based temperature instrument (TempTouchRM®) that is intended for home use by high-risk diabetic patients. This step-on remote monitoring device will serve as an early warning system for impending ulcers and Charcot fractures. 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.

Condition or disease Intervention/treatment
Diabetes Neuropathic Limb Elevated Temperature Shear Pressure Increased Temperatures Device: TempTouchRM Device: Offloading

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Novel Home Care Device for High-Risk Diabetic Patients
Study Start Date : January 2007
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Primary Outcome Measures :
  1. incident foot ulcers [ Time Frame: one year ]

Secondary Outcome Measures :
  1. temperature spikes on foot zones [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500175

Contact: Kevin R HIggins, DPM (210) 657-2644 higgins@xilas.com
Contact: Ruben G Zamorano, MSW, MPH (210) 692-1114 ext 119 zamorano@xilas.com

United States, Texas
Kevin R. Higgins, DPM Recruiting
San Antonio, Texas, United States, 78217
Contact: Ruben G Zamorano, MSW, MPH    210-692-1114 ext 119    zamorano@xilas.com   
Sponsors and Collaborators
Diabetica Solutions Inc.
National Institutes of Health (NIH)
Principal Investigator: Kevin R Higgins, DPM

ClinicalTrials.gov Identifier: NCT00500175     History of Changes
Other Study ID Numbers: DK061815
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: July 2007

Keywords provided by Diabetica Solutions Inc.:
pressure sores
shear friction

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms