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| Name | Class |
|---|---|
| Avex LLC | INDUSTRY |
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Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene.
A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc).
The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avex Footbeat | Experimental | Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avex Footbeat | Device | Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance From Baseline to 4 Weeks | Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm. | baseline and 4 weeks. |
| Change in Skin Perfusion From Baseline to 4 Weeks | Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Edema From Baseline to 4 Weeks | Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm. | Baseline and 4 weeks |
| Change in Plantar Sensation From Baseline to 4-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30943782 | Result | Kang GE, Zahiri M, Lepow B, Saleem N, Najafi B. The Effect of Daily Use of Plantar Mechanical Stimulation Through Micro-Mobile Foot Compression Device Installed in Shoe Insoles on Vibration Perception, Gait, and Balance in People With Diabetic Peripheral Neuropathy. J Diabetes Sci Technol. 2019 Sep;13(5):847-856. doi: 10.1177/1932296819839703. Epub 2019 Apr 3. |
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Only de-identified data and associated results will be published in peer-review papers or scientific abstracts. The de-identified data from changes in primary and secondary outcomes (e.g. changes in balance, gait, physical activity, edema, etc) may be shared upon approval of the sponsor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avex Footbeat | Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day. Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avex Footbeat | Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day. Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion. |
| 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 | Change in Balance From Baseline to 4 Weeks | Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm. | Posted | Mean | Standard Deviation | cm | baseline and 4 weeks. |
|
4 weeks
Serious adverse event (SAE) was defined as any related incident of foot ulcer caused by the proposed footwear/insole
Other adverse event (AE) was defined as any related major pain or any other problems associated with provided footwear (e.g. edema, skin redness, callus, etc)
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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 | Avex Footbeat | Subjects will receive a new pair of diabetic shoes with BOA shoelace closure and a pair of AVEX Footbeat insoles, which include a micro-mobile compression pump. The entire system is named 'intervention shoes' for simplicity. They will be instructed to wear the intervention shoes on daily basis for 4 weeks for duration of at least 4 hours per day. Avex Footbeat: Subjects will receive diabetic shoes equipped with Boa Technology shoelace system and Footbeat compression insoles, which for simplicity will be named intervention shoes. All participants will be asked to wear the intervention shoes for duration of 4-weeks on daily basis (minimum 4 hours per day). Daily use of the intervention shoes will be assumed to improve balance, mobility, plantar sensation, lower extremity edema, and lower extremity skin perfusion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. | Baylor College of Medicine | 17137987536 | bijan.najafi@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2018 | Feb 12, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009443 | Neuritis |
| D017719 | Diabetic Foot |
| D008206 | Lymphatic Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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The change in plantar sensation after 4-weeks use of AVEX Footbeat will be assessed using vibratory perception threshold (VPT) test. The unit of this measurement is volt.
| Baseline to 4 weeks |
| Change in Stride Velocity From Baseline to 4-week | The change in stride velocity was quantified by gait speed measured using a validated wearable sensor (LEGSys, Biosensics, LLC). The unit of measurement is meter per second (m/s) | Baseline to 4 weeks |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Skin Perfusion From Baseline to 4 Weeks | Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg. | Posted | Mean | Standard Deviation | mmHg | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Lower Extremity Edema From Baseline to 4 Weeks | Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm. | Posted | Mean | Standard Deviation | cm | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Plantar Sensation From Baseline to 4-week | The change in plantar sensation after 4-weeks use of AVEX Footbeat will be assessed using vibratory perception threshold (VPT) test. The unit of this measurement is volt. | Posted | Mean | Standard Deviation | volts | Baseline to 4 weeks |
|
|
|
| Secondary | Change in Stride Velocity From Baseline to 4-week | The change in stride velocity was quantified by gait speed measured using a validated wearable sensor (LEGSys, Biosensics, LLC). The unit of measurement is meter per second (m/s) | Posted | Mean | Standard Deviation | m/s | Baseline to 4 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D006425 | Hemic and Lymphatic Diseases |