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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Diabetica Solutions Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Diabetica Solutions Inc.
ClinicalTrials.gov Identifier:
NCT00500175
First received: July 10, 2007
Last updated: July 11, 2007
Last verified: July 2007
  Purpose

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 Intervention
Diabetes
Neuropathic Limb
Elevated Temperature
Shear Pressure
Increased Temperatures
Device: TempTouchRM
Device: Offloading

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Novel Home Care Device for High-Risk Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Diabetica Solutions Inc.:

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

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

Estimated Enrollment: 110
Study Start Date: January 2007
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500175

Contacts
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

Locations
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.
Investigators
Principal Investigator: Kevin R Higgins, DPM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00500175     History of Changes
Other Study ID Numbers: DK061815
Study First Received: July 10, 2007
Last Updated: July 11, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Fever
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014