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TempTouch IR Thermometry & Diabetic Patient Self-Care

NCT00289497 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2006-02-09

No results posted yet for this study

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 wound develops. Areas about to ulcerate become inflamed and "hot spots" can be identified. This study's purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify "hot spots." Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated \>4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.

Conditions

  • Diabetic Polyneuropathy
  • Diabetic Foot Ulcer
  • Diabetes
  • Foot Infection

Interventions

DEVICE

TempTouch®

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Diabetica Solutions Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin R Higgins, DPM · Xilas Medical, Inc

  • C. Mauli Agrawal, Ph.D. · Xilas Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-06-30
Completion
2003-07-31

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 NCT00289497 on ClinicalTrials.gov