NCT00289497

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2000

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
Last Updated

February 9, 2006

Status Verified

February 1, 2006

First QC Date

February 7, 2006

Last Update Submit

February 8, 2006

Conditions

Diabetic PolyneuropathyDiabetic Foot UlcerDiabetesFoot Infection

Keywords

Charcotfootulcerationneuropathy

Outcome Measures

Primary Outcomes (1)

  • Intervention of device use decreases foot ulcers.

Secondary Outcomes (1)

  • Comparison of foot ulceration from enhanced device group as opposed to control group.

Interventions

TempTouch®DEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of diabetes by WHO criteria
  • ability to provide informed consent
  • years of age

You may not qualify if:

  • 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
  • other conditions based on the PI's clinical judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Steven R Beito, DPM

New Braunfels, Texas, 78130, United States

Location

Robert Wunderlich, DPM

San Antonio, Texas, 78212, United States

Location

8800 Village Drive, Suite 202

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

  • Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642.

    PMID: 15504999RESULT

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetic FootDiabetes MellitusUlcer

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin R Higgins, DPM

    Xilas Medical, Inc

    PRINCIPAL INVESTIGATOR

  • C. Mauli Agrawal, Ph.D.

    Xilas Medical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

June 1, 2000

Study Completion

July 1, 2003

Last Updated

February 9, 2006

Record last verified: 2006-02

Locations

US(3)