N/A
Completed N=132
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
Foot Ulcer, Diabetic
Source: ClinicalTrials.gov NCT02647346 ↗
Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Occurrence of Plantar Diabetic Foot Ulcer — 37 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Plantar Diabetic Foot Ulcer |
37 | — |
| SECONDARY Subject Adherence in Daily Use of the Study Device |
5.5 | — |
| SECONDARY Device-related Trips/Falls |
— | — |
| SECONDARY Device-related Injuries |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02647346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.