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Novel Home Care Device for High-Risk Diabetic Patients

NCT00500175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2007-07-12

No results posted yet for this study

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.

Conditions

  • Diabetes
  • Neuropathic Limb
  • Elevated Temperature
  • Shear Pressure
  • Increased Temperatures

Interventions

DEVICE

TempTouchRM

DEVICE

Offloading

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Diabetica Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin R Higgins, DPM

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500175 on ClinicalTrials.gov