Micro-mobile Foot Compression and Diabetic Foot
Condition: Diabetes; PAD; Lower Extremity Edema; Neuropathy;Peripheral; Foot Ulcer, Diabetic; Lymphatic Diseases
MeSH terms: Peripheral Nervous System Diseases; Diabetic Foot; Lymphatic Diseases; Foot Ulcer
Intervention: Avex Footbeat
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.