Clinical trial NCT03135535: Micro-mobile Foot Compression and Diabetic Foot
Official title: Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
PAD
Lower Extremity Edema
Neuropathy;Peripheral
Foot Ulcer, Diabetic
Lymphatic Diseases
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Avex LLC
First posted: 2017-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Balance From Baseline to 4 Weeks
timeFrame: baseline and 4 weeks.
measure: Change in Skin Perfusion From Baseline to 4 Weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Lower Extremity Edema From Baseline to 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change in Plantar Sensation From Baseline to 4-week
timeFrame: Baseline to 4 weeks
measure: Change in Stride Velocity From Baseline to 4-week
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: 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.