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

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647346
• Other study ID #: P-04
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2020
• Source: Podimetrics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• Daily use of podimetrics smart-foot mat

Locations

Country	Name	City	State
United States	Center for Clinical Research Castro Valley	Castro Valley	California
United States	MetroWest Medical Center	Framingham	Massachusetts
United States	Limb Preservation Platform	Fresno	California
United States	Greenville Health System	Greenville	South Carolina
United States	VA Long Beach Health System	Long Beach	California
United States	Miami VA Healthcare System	Miami	Florida
United States	Phoenix VA Health Care System	Phoenix	Arizona
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Podimetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Plantar Diabetic Foot Ulcer		Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary	Subject Adherence in Daily Use of the Study Device		Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary	Device-related Trips/Falls		Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary	Device-related Injuries		Through study completion or subject withdrawal (34 weeks per-protocol)