Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear
Condition: Diabetes Mellitus Type 2; Sensory Neuropathy; Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of
      the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes
      versus normal foot wear in diabetic and healthy subjects.
    

Detailed description: 
      Every 30 seconds a limb is lost somewhere in the world as a consequence of diabetes. These
      amputations are preceded by a foot ulcer in 84% of cases. Therefore, prevention of ulceration
      is of utmost importance.

      Approximately one-half of all diabetic foot ulcers occur on the plantar foot surface and are
      mainly caused by elevated levels of mechanical pressure acting on the foot during ambulation
      in the presence of lost protective foot sensation from peripheral neuropathy.

      Therefore, to reduce risk of ulceration, relief of mechanical pressure (also called
      offloading) is indicated.

      Currently therapeutic footwear is provided by the Health maintenance organizations (HMO's) to
      diabetic patients that are at risk of developing foot ulcers.

      Ideal footwear for a diabetic patient decreases weight-bearing pressure and shear forces
      applied to the skin of the foot by distributing the acting forces more evenly.

      With the growth in the health and fitness industry, sports footwear has shown technological
      advances and diversification.

      The introduction of the KyBoot shoe is an example of this diversification. The Kybun company
      based their shoe on the experience of walking on soft, muddy rice fields in Korea.

      The Kyboot construction is based on a soft, supple air cushioned sole. The honeycomb air
      structure of the kyBoot sole creates an air cushion between your foot and the ground, with
      one fifth of the volume of air being pumped into the foot area at every step. This design
      could offer a better distribution of pressure.

      Therefore, in this study we would like to compare the pressure distribution, changes in the
      movement of the center of pressure and shock absorbing capabilities of the KyBoot in
      comparison with normal shoes.

      Study goals:

      Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of
      the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes
      versus normal foot wear in diabetic and healthy subjects.
    

Intervention name(s): Kyboot shoes
Intervention type(s): Device
Intervention description(s): The Kyboot shoe - construction is based on a soft, supple air cushioned sole. The honeycomb air structure of the kyBoot sole creates an air cushion between your foot and the ground, with one fifth of the volume of air being pumped into the foot area at every step. This design could offer a better distribution of pressure
Other intervention name(s): Kybun shoe
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science