Diabetes, Foot Ulcer, Diabetic, Lower Extremity Edema, Lymphatic Diseases, Neuropathy;Peripheral, PAD
Conditions
Brief summary
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.
Interventions
DEVICEAvex 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.
Sponsors
Avex LLC
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female , age 18 or older with the ability and willingness to provide Informed consent * Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study * History of type 2 diabetes confirmed by patient's physician. * History of peripheral neurpathy .
Exclusion criteria
* Patients with severe peripheral vascular disease (ankle-brachial systolic pressure index (ABI) \<0.5 or ABI\>1.30) * Patients with active wound infection, or untreated osteomyelitis * Patients with major foot deformities (e.g. Charcot Foot) or major amputation (e.g. above ankle) * Unamulatory of those who are unable to independently walk with or without walking assistance, a distance of 40 feet. * Patients who are unable or unwilling to participate in all procedures and follow up evaluations * Patients currently on immunosuppressive drugs. * Pregnant or breast feeding ladies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Balance From Baseline to 4 Weeks | baseline and 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. |
| Change in Skin Perfusion From Baseline to 4 Weeks | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Edema From Baseline to 4 Weeks | Baseline and 4 weeks | Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm. |
| Change in Plantar Sensation From Baseline to 4-week | Baseline to 4 weeks | 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. |
| Change in Stride Velocity From Baseline to 4-week | Baseline to 4 weeks | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Avex Footbeat |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 68.1 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: baseline and 4 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avex Footbeat | Change in Balance From Baseline to 4 Weeks | At Baseline | 0.94 cm | Standard Deviation 0.43 |
| Avex Footbeat | Change in Balance From Baseline to 4 Weeks | At 4-week | 0.76 cm | Standard Deviation 0.32 |
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.
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avex Footbeat | Change in Skin Perfusion From Baseline to 4 Weeks | At Baseline | 75.1 mmHg | Standard Deviation 15.8 |
| Avex Footbeat | Change in Skin Perfusion From Baseline to 4 Weeks | At 4-week | 75.7 mmHg | Standard Deviation 11.1 |
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.
Time frame: Baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avex Footbeat | Change in Lower Extremity Edema From Baseline to 4 Weeks | Baseline | 23.1 cm | Standard Deviation 2.6 |
| Avex Footbeat | Change in Lower Extremity Edema From Baseline to 4 Weeks | @4week | 23.0 cm | Standard Deviation 2.4 |
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.
Time frame: Baseline to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avex Footbeat | Change in Plantar Sensation From Baseline to 4-week | At Baseline | 27.4 volts | Standard Deviation 12.6 |
| Avex Footbeat | Change in Plantar Sensation From Baseline to 4-week | At 4-week | 23.3 volts | Standard Deviation 11.9 |
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)
Time frame: Baseline to 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avex Footbeat | Change in Stride Velocity From Baseline to 4-week | At 4-week | 0.96 m/s | Standard Deviation 0.23 |
| Avex Footbeat | Change in Stride Velocity From Baseline to 4-week | At Baseline | 0.87 m/s | Standard Deviation 0.21 |