In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.

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Detailed Description

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Conditions

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Foot Ulcer, Diabetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participant cohort

Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.

Group Type EXPERIMENTAL

Daily use of podimetrics smart-foot mat

Intervention Type DEVICE

Interventions

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Daily use of podimetrics smart-foot mat

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male/Female, 18 years or older
* Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled
* Ankle Brachial Index (ABI) \>0.5
* Patient with history of previous foot ulcer.

Exclusion Criteria

* Active Charcot foot disease
* One or more plantar foot ulcers (UT Grade 1A-C, 2A-C \& 3A-C)
* Active Infection/Gangrene
* Active malignancy
* Immunosuppressive disease
* History of alcohol or drug abuse
* Pregnant women (verbal confirmation or confirmation obtained within current medical records)
* Cognitive deficit
* 2+ or great lower extremity edema
* End stage renal disease
* History of major lower extremity amputation (below knee or above knee amputation)
* Other issue that, at the discretion of the investigator, renders the subject ineligible for participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No