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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Kyboot shoes
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy subjects

Diabetic patients

Arm Description

Kyboot shoes will be administered to the healthy subjects. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.

Kyboot shoes will be administered to the diabetic patients. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.

Outcomes

Primary Outcome Measures

Reduction of Peak Pressure
The pressure distribution will be measured by in-sole pressure sensors.

Secondary Outcome Measures

Comfort of wear
Comfort of wear will be evaluated with the help of a questionnaire

Full Information

First Posted
May 20, 2015
Last Updated
January 26, 2016
Sponsor
Sheba Medical Center
Collaborators
Kybun AG
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1. Study Identification

Unique Protocol Identification Number
NCT02451722
Brief Title
Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear
Acronym
Kyboot
Official Title
Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear in Diabetic Patients and in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Kybun AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Sensory Neuropathy, Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
Kyboot shoes will be administered to the healthy subjects. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
Arm Title
Diabetic patients
Arm Type
Active Comparator
Arm Description
Kyboot shoes will be administered to the diabetic patients. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
Intervention Type
Device
Intervention Name(s)
Kyboot shoes
Other Intervention Name(s)
Kybun shoe
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of Peak Pressure
Description
The pressure distribution will be measured by in-sole pressure sensors.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Comfort of wear
Description
Comfort of wear will be evaluated with the help of a questionnaire
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itzhak Siev-Ner, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
16291066
Citation
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.
Results Reference
background
PubMed Identifier
2351029
Citation
Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990 May;13(5):513-21. doi: 10.2337/diacare.13.5.513.
Results Reference
background
PubMed Identifier
10834417
Citation
Pham H, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial. Diabetes Care. 2000 May;23(5):606-11. doi: 10.2337/diacare.23.5.606.
Results Reference
background
PubMed Identifier
17093942
Citation
Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. doi: 10.1007/s00125-006-0491-1. Epub 2006 Nov 9.
Results Reference
background
PubMed Identifier
18442178
Citation
Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlavacek P, Bakker K, Cavanagh PR. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S162-80. doi: 10.1002/dmrr.850.
Results Reference
background
Links:
URL
http://www.kybun.com
Description
The company providing the Kyboot shoe

Learn more about this trial

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

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