An interventional study of Daily use of podimetrics smart-foot mat in Foot Ulcer, Diabetic, sponsored by Podimetrics, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Podimetrics, Inc. · Not applicable, Interventional, and Diagnostic
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 132 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Podimetrics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
Device: Daily use of podimetrics smart-foot mat
Occurrence of Plantar Diabetic Foot Ulcer
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Subject Adherence in Daily Use of the Study Device
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Trips/Falls
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
Device-related Injuries
Time frame: Through study completion or subject withdrawal (34 weeks per-protocol)
| Milestone | Participant Cohort |
|---|---|
| Started | 132 |
| Completed | 129 |
| Not completed | 3 |
| Participants | Participant Cohort |
|---|---|
| Occurrence of Plantar Diabetic Foot Ulcer | 37 |
| uses/week | Participant Cohort |
|---|---|
| Subject Adherence in Daily Use of the Study Device | 5.5 ± 1.2 |
| occurence | Participant Cohort |
|---|---|
| Device-related Trips/Falls | 0 |
| occurence | Participant Cohort |
|---|---|
| Device-related Injuries | 0 |
Collected over 34 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participant Cohort | 3/132 (2.3%) | 0/132 (0%) | 0/132 (0%) |
| Age, Categorical(Participants) | Participant Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 55 |
| >=65 years | 74 |
| Age, Continuous(years) | Participant Cohort |
|---|---|
| Mean | 65 ± 10.5 |
| Sex: Female, Male(Participants) | Participant Cohort |
|---|---|
| Female | 18 |
| Male | 111 |
| Race/Ethnicity, Customized(Participants) | Participant Cohort |
|---|---|
| Racial Origin — African American | 19 |
| Racial Origin — American Indian | 1 |
| Racial Origin — Asian | 2 |
| Racial Origin — Caucasian | 76 |
| Racial Origin — Hispanic/Latino | 26 |
| Racial Origin — Native American | 3 |
| Racial Origin — Unspecified | 2 |
| Region of Enrollment(participants) | Participant Cohort |
|---|---|
| United States | 129 |
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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