In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT02647346 |
Recruitment Status :
Completed
First Posted : January 6, 2016
Results First Posted : February 5, 2020
Last Update Posted : February 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Foot Ulcer, Diabetic | Device: Daily use of podimetrics smart-foot mat | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Participant cohort
Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment.
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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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647346
United States, Arizona | |
Phoenix VA Health Care System | |
Phoenix, Arizona, United States, 85012 | |
University of Arizona | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Center for Clinical Research Castro Valley | |
Castro Valley, California, United States, 94546 | |
Limb Preservation Platform | |
Fresno, California, United States, 93721 | |
VA Long Beach Health System | |
Long Beach, California, United States, 90822 | |
United States, Florida | |
Miami VA Healthcare System | |
Miami, Florida, United States, 33125 | |
United States, Massachusetts | |
MetroWest Medical Center | |
Framingham, Massachusetts, United States, 01702 | |
United States, South Carolina | |
Greenville Health System | |
Greenville, South Carolina, United States, 29615 |
Responsible Party: | Podimetrics, Inc. |
ClinicalTrials.gov Identifier: | NCT02647346 |
Other Study ID Numbers: |
P-04 |
First Posted: | January 6, 2016 Key Record Dates |
Results First Posted: | February 5, 2020 |
Last Update Posted: | February 21, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diabetic Foot Foot Ulcer Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer |
Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases |