Micro-mobile Foot Compression and Diabetic Foot

Phase 2

Completed

Conditions: Lower Extremity Edema
Lymphatic Diseases
Diabetes
Neuropathy;Peripheral
PAD
Foot Ulcer, Diabetic

Interventions: Device: Avex Footbeat

Registration Number: NCT03135535

Lead Sponsor: Baylor College of Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avex Footbeat	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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.