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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant cohort | Experimental | Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily use of podimetrics smart-foot mat | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Plantar Diabetic Foot Ulcer | Through study completion or subject withdrawal (34 weeks per-protocol) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System | Phoenix | Arizona | 85012 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31956341 | Derived | Petersen BJ, Rothenberg GM, Lakhani PJ, Zhou M, Linders DR, Bloom JD, Wood KA, Armstrong DG. Ulcer metastasis? Anatomical locations of recurrence for patients in diabetic foot remission. J Foot Ankle Res. 2020 Jan 13;13:1. doi: 10.1186/s13047-020-0369-3. eCollection 2020. | |
| 28465454 | Derived | Frykberg RG, Gordon IL, Reyzelman AM, Cazzell SM, Fitzgerald RH, Rothenberg GM, Bloom JD, Petersen BJ, Linders DR, Nouvong A, Najafi B. Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Diabetes Care. 2017 Jul;40(7):973-980. doi: 10.2337/dc16-2294. Epub 2017 May 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participant Cohort | Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participant Cohort | Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Plantar Diabetic Foot Ulcer | Posted | Count of Participants | Participants | Through study completion or subject withdrawal (34 weeks per-protocol) |
|
|
34 weeks
Per the original definition of adverse event in the protocol, diabetic foot ulcer occurrence does not constitute as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participant Cohort | Participants with diabetes that each have a history of healed Diabetic Foot Ulcer (DFU) prior to enrollment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Petersen | Podimetrics Inc | 860-558-9204 | brian@podimetrics.com |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Device-related Injuries | Through study completion or subject withdrawal (34 weeks per-protocol) |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Center for Clinical Research Castro Valley | Castro Valley | California | 94546 | United States |
| Limb Preservation Platform | Fresno | California | 93721 | United States |
| VA Long Beach Health System | Long Beach | California | 90822 | United States |
| Miami VA Healthcare System | Miami | Florida | 33125 | United States |
| MetroWest Medical Center | Framingham | Massachusetts | 01702 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Subject Adherence in Daily Use of the Study Device | Posted | Mean | Standard Deviation | uses/week | Through study completion or subject withdrawal (34 weeks per-protocol) |
|
|
|
| Secondary | Device-related Trips/Falls | Posted | Number | occurence | Through study completion or subject withdrawal (34 weeks per-protocol) |
|
|
|
| Secondary | Device-related Injuries | Posted | Number | occurence | Through study completion or subject withdrawal (34 weeks per-protocol) |
|
|
|
| 3 |
| 132 |
| 0 |
| 132 |
| 0 |
| 132 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |