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Completed

NCT Number: NCT02647346

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

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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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix VA Health Care System, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily use of podimetrics smart-foot mat

Device

Primary outcomes

  1. Occurrence of Plantar Diabetic Foot Ulcer

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

Secondary outcomes

  1. Subject Adherence in Daily Use of the Study Device

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

  2. Device-related Trips/Falls

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

  3. Device-related Injuries

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

Sponsors and collaborators

Lead sponsor

Podimetrics, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2016
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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