Novel Home Care Device for High-Risk Diabetic Patients

NCT00500175 | Unknown DMC

• 1 other identifier: DK061815
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetes; ulceration; amputation; pressure sores; shear friction

Outcome Measures

Primary Outcomes (1)

• incident foot ulcers

  one year

Secondary Outcomes (1)

• temperature spikes on foot zones

  one year

Interventions

TempTouchRM DEVICE

Offloading DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80 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, or other conditions based on the PI's clinical judgment.

Sponsors & Collaborators

• Diabetica Solutions Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Kevin R. Higgins, DPM

San Antonio, Texas, 78217, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Fever; Ulcer; Pressure Ulcer

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kevin R Higgins, DPM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin R HIggins, DPM

CONTACT

(210) 657-2644; higgins@xilas.com

Ruben G Zamorano, MSW, MPH

CONTACT

(210) 692-1114; zamorano@xilas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: January 1, 2007
• Study Completion: June 1, 2008
• Last Updated: July 12, 2007

Record last verified: 2007-07

Locations

US (1)