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Clinical Trials/NCT02647346
NCT02647346
Completed
Not Applicable

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

Podimetrics, Inc.8 sites in 1 country132 target enrollmentNovember 2013
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ConditionsFoot Ulcer, Diabetic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Ulcer, Diabetic
Sponsor
Podimetrics, Inc.
Enrollment
132
Locations
8
Primary Endpoint
Occurrence of Plantar Diabetic Foot Ulcer
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurrence of Plantar Diabetic Foot Ulcer

Time Frame: Through study completion or subject withdrawal (34 weeks per-protocol)

Secondary Outcomes

  • Device-related Trips/Falls(Through study completion or subject withdrawal (34 weeks per-protocol))
  • Subject Adherence in Daily Use of the Study Device(Through study completion or subject withdrawal (34 weeks per-protocol))
  • Device-related Injuries(Through study completion or subject withdrawal (34 weeks per-protocol))

Study Sites (8)

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