Clinical trial NCT02647346: In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Official title: In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Podimetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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
* 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.

Primary outcomes:
measure: Occurrence of Plantar Diabetic Foot Ulcer
timeFrame: Through study completion or subject withdrawal (34 weeks per-protocol)
Secondary outcomes:
measure: Subject Adherence in Daily Use of the Study Device
timeFrame: Through study completion or subject withdrawal (34 weeks per-protocol)
measure: Device-related Trips/Falls
timeFrame: Through study completion or subject withdrawal (34 weeks per-protocol)
measure: Device-related Injuries
timeFrame: Through study completion or subject withdrawal (34 weeks per-protocol)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research Castro Valley
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Long Beach
country: United States
facility: VA Long Beach Health System
state: California
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
References:
citation: 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.
citation: 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.