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

January 26, 2016 updated by: Dr. Itzhak Siev-Ner, Sheba Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy subjects

Kyboot shoes will be administered to the healthy subjects.

Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
Device: Kyboot shoes
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 Names:
  • Kybun shoe
Active Comparator: Diabetic patients

Kyboot shoes will be administered to the diabetic patients.

Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
Device: Kyboot shoes
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 Names:
  • Kybun shoe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Peak Pressure
Time Frame: 1 day
The pressure distribution will be measured by in-sole pressure sensors.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort of wear
Time Frame: 1 Day
Comfort of wear will be evaluated with the help of a questionnaire
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Kybun AG

Investigators

  • Principal Investigator: Itzhak Siev-Ner, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-2053-15-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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