Micro-mobile Foot Compression and Diabetic Foot

Baylor College of Medicine

Status and phase: Completed; Phase 2

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

Treatments: Device: Avex Footbeat

Study type: Interventional

Funder types: Other

Identifiers

NCT03135535

H-37962

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Avex Footbeat

Experimental group

Description:

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.

Treatment:

Device: Avex Footbeat