Foot Ulcer, Diabetic
Conditions
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.
Interventions
DEVICEDaily use of podimetrics smart-foot mat
Sponsors
Podimetrics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Plantar Diabetic Foot Ulcer | Through study completion or subject withdrawal (34 weeks per-protocol) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participant Cohort Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Participant Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 74 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized Racial Origin African American | 19 Participants |
| Race/Ethnicity, Customized Racial Origin American Indian | 1 Participants |
| Race/Ethnicity, Customized Racial Origin Asian | 2 Participants |
| Race/Ethnicity, Customized Racial Origin Caucasian | 76 Participants |
| Race/Ethnicity, Customized Racial Origin Hispanic/Latino | 26 Participants |
| Race/Ethnicity, Customized Racial Origin Native American | 3 Participants |
| Race/Ethnicity, Customized Racial Origin Unspecified | 2 Participants |
| Region of Enrollment United States | 129 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 132 |
| other Total, other adverse events | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 |
Outcome results
Primary
Occurrence of Plantar Diabetic Foot Ulcer
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participant Cohort | Occurrence of Plantar Diabetic Foot Ulcer | 37 Participants |
Secondary
Device-related Injuries
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Cohort | Device-related Injuries | 0 occurence |
Secondary
Device-related Trips/Falls
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Cohort | Device-related Trips/Falls | 0 occurence |
Secondary
Subject Adherence in Daily Use of the Study Device
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Cohort | Subject Adherence in Daily Use of the Study Device | 5.5 uses/week | Standard Deviation 1.2 |