Recruiting

Home Care Device

Sponsor:

Diabetica Solutions Inc.

Code:

NCT00500175

Conditions

Diabetes

Neuropathic Limb

Elevated Temperature

Shear Pressure

Increased Temperatures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TempTouchRM

Offloading

Study Details

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

Study ID

NCT00500175

Start date

Jan, 2007

Status verified date

Jul, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80 years of age.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

TempTouchRM

Offloading

Primary outcome measure

  • incident foot ulcers [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Ruben G Zamorano, MSW, MPH

(210) 692-1114zamorano@xilas.com

Locations

Kevin R. Higgins, DPM

Recruiting

San Antonio, Texas, United States, 78217

Contacts

Ruben G Zamorano, MSW, MPH

210-692-1114zamorano@xilas.com

More Information

Sponsor

Diabetica Solutions Inc.

Last update posted

Jul 12, 2007

Last verified

Jul, 2007

Keywords

  • diabetes
  • ulceration
  • amputation
  • pressure sores
  • shear friction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Diabetica Solutions Inc. on 2007-07-12.