TempTouch IR Thermometry & Diabetic Patient Self-Care
Public ClinicalTrials.gov record NCT00289497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Study for Infrared Thermometry Used by Diabetic Patients at Home
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00289497
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 180 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2000
- Primary completion
- Not listed
- Completion
- Jun 30, 2003
- Last update posted
- Feb 8, 2006
2000 – 2003
United States locations
- U.S. sites
- 3
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Steven R Beito, DPM | New Braunfels | Texas | 78130 | — |
| Robert Wunderlich, DPM | San Antonio | Texas | 78212 | — |
| 8800 Village Drive, Suite 202 | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00289497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2006 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00289497 live on ClinicalTrials.gov.