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

Podimetrics

Status: Completed

Conditions: Foot Ulcer, Diabetic

Treatments: Device: Daily use of podimetrics smart-foot mat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02647346

P-04

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

132 participants in 1 patient group

Participant cohort

Experimental group

Description:

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

Treatment:

Device: Daily use of podimetrics smart-foot mat