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Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear

Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear in Diabetic Patients and in Healthy Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02451722
Acronym
Kyboot
Enrollment
21
Registered
2015-05-22
Start date
2015-05-31
Completion date
2015-11-30
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Foot Ulcer, Diabetic, Sensory Neuropathy

Brief 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.

Interventions

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

Sponsors

Kybun AG
CollaboratorUNKNOWN
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

( for the group of diabetic patients) * Signing of informed consent * Diabetes mellitus Type 2 * No major foot deformations necessitating fitting of personalized foot wear * Absence of diabetic foot ulcers and existence of sensory neuropathy confirmed by a physician * Intact cognitive function * Normal Gait

Exclusion criteria

* An orthopedic or rheumatic disease that negatively influences range of motion, strength, gait or balance * Neurological diseases that influence proprioception , strength, balance, cognitive function / understanding, sight: Cerebro-vascular accident, Dementia, Spinal Cord injury, Head injury, Parkinson etc. * Injury or disease that can influence normal gait * Need for assistive devices : Crutches, cane, walker * Dialysis Treatment

Design outcomes

Primary

MeasureTime frameDescription
Reduction of Peak Pressure1 dayThe pressure distribution will be measured by in-sole pressure sensors.

Secondary

MeasureTime frameDescription
Comfort of wear1 DayComfort of wear will be evaluated with the help of a questionnaire

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026