NCT02647346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

January 4, 2016

Results QC Date

January 14, 2020

Last Update Submit

February 8, 2020

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Plantar Diabetic Foot Ulcer

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

Secondary Outcomes (3)

  • Subject Adherence in Daily Use of the Study Device

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

  • Device-related Trips/Falls

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

  • Device-related Injuries

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

Study Arms (1)

Participant cohort

EXPERIMENTAL

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

Device: Daily use of podimetrics smart-foot mat

Interventions

Daily use of podimetrics smart-foot matDEVICE
Participant cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • + 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Center for Clinical Research Castro Valley

Castro Valley, California, 94546, United States

Location

Limb Preservation Platform

Fresno, California, 93721, United States

Location

VA Long Beach Health System

Long Beach, California, 90822, United States

Location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

MetroWest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

Related Publications (2)

  • Petersen BJ, Rothenberg GM, Lakhani PJ, Zhou M, Linders DR, Bloom JD, Wood KA, Armstrong DG. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020 Jan 13;13:1. doi: 10.1186/s13047-020-0369-3. eCollection 2020.

    PMID: 31956341DERIVED

  • Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2.

    PMID: 28465454DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Results Point of Contact

Title
Brian Petersen
Organization
Podimetrics Inc
brian@podimetrics.com
860-558-9204

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 6, 2016

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 21, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)