Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
Condition: Diabetic Foot Ulcer; Offloading
MeSH terms: Diabetic Foot; Foot Ulcer
Intervention: Offloading boot: PulseFlow
Intervention description: A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes.
      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, resulting in staggering costs for both
      the patient and the healthcare system. Prevention by identifying people at higher risk is key
      for better clinical management of such patients. It is not uncommon for patients suffering
      from diabetes to have concomitant lower extremity edema or 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
      possibility of gangrene.

      A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot
      Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The
      device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and
      offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back
      to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The
      offloading boot design holds the foot and lower leg in a position that reduces shear and
      friction forces and provides a reduction in plantar pressure.

      The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This
      data will be downloaded at each clinic visit. The boot cannot pump blood around the
      participant's foot unless fitted correctly and the battery is charged up overnight.

      The purpose of this study is to conduct an interventional study study with N=15 diabetic
      subjects with active foot ulcers to assess whether PulseFlow foot compression device can help
      improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of
      gait.

      The key goals of the proposed project are to test whether a specially designed compression
      device can improve lower extremity perfusion, whilst also simultaneously improving the
      balance and walking performance. Investigators envision the use of this specially designed
      offloading device with compression capability will help reduce the incidence of diabetic foot
      ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device
      might enhance daily physical activity as well as walking performance. Investigators will
      conduct a prospective clinical study to validate these hypotheses. Potential changes in
      walking and spontaneous daily physical activities will be assessed using validated
      technologies that include walking analyzer system, balance assessment using body worn
      sensors, and computerized pressure insoles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18- 80 years old

          -  type II diabetes with active plantar ulcer,

        Exclusion Criteria:

          -  Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet
             without assistance

          -  Plantar ulcer on arch of the foot

          -  Patients with PAD (Ankle Brachial Index < 0.5)

          -  Acute foot fracture

          -  Heart failure

          -  Pregnant women

          -  Patients on immunosuppressive drugs

          -  Participation in an interventional study in the last 30 days

          -  Major amputation

          -  Patients unable or unwilling to participate in all procedures and follow-up
             evaluations.