Micro-mobile Foot Compression and Diabetic Foot



Status:Completed
Conditions:Lymphoma, Neurology, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Neurology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:May 2, 2017
End Date:December 15, 2018

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

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.


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.
We found this trial at
1
site
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 713-798-7536
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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mi
from
Houston, TX
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