Micro-mobile Foot Compression and Diabetic Foot

NCT03135535 — Phase 2, Completed, 30 participants, Baylor College of Medicine

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Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation

Registry	NCT03135535
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	30 (Actual)
Sponsor	Baylor College of Medicine (Other); collaborators: Avex LLC
Conditions	Diabetes, PAD, Lower Extremity Edema, Neuropathy;Peripheral, Foot Ulcer, Diabetic, Lymphatic Diseases
Interventions	Avex Footbeat (Device)
Dates	start 2017-05-02, primary completion 2018-09-09, completion 2021-05-14, first posted 2017-05-01, last updated 2021-10-28
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Avex Footbeat	Experimental	Device: 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 (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.

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Posted results

Participant flow

Milestone	Avex Footbeat
Started	30
Completed	30
Not completed	0

Outcome results

Change in Balance From Baseline to 4 Weeks (Primary), Mean, cm: Avex Footbeat 0.94 +/- 0.43
Change in Skin Perfusion From Baseline to 4 Weeks (Primary), Mean, mmHg: Avex Footbeat 75.1 +/- 15.8
Change in Lower Extremity Edema From Baseline to 4 Weeks (Secondary), Mean, cm: Avex Footbeat 23.1 +/- 2.6
Change in Plantar Sensation From Baseline to 4-week (Secondary), Mean, volts: Avex Footbeat 27.4 +/- 12.6
Change in Stride Velocity From Baseline to 4-week (Secondary), Mean, m/s: Avex Footbeat 0.87 +/- 0.21

Adverse events

Time frame: 4 weeks

Arm	Deaths	Serious adverse events	Other adverse events
Avex Footbeat	0/30 (0.0%)	0/30 (0.0%)	0/30 (0.0%)

+Locations (1)

Facility	City	Country	Status
Baylor College of Medicine	Houston, Texas	United States

+Publications

Results publication: 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. PMID 30943782

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2018-07-10)

My Notes

Public

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