Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear
Kyboot
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started May 2015
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 27, 2016
January 1, 2016
6 months
May 20, 2015
January 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of Peak Pressure
The pressure distribution will be measured by in-sole pressure sensors.
1 day
Secondary Outcomes (1)
Comfort of wear
1 Day
Study Arms (2)
Healthy subjects
ACTIVE COMPARATORKyboot shoes will be administered to the healthy subjects. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
Diabetic patients
ACTIVE COMPARATORKyboot shoes will be administered to the diabetic patients. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Kybun AGcollaborator
Study Sites (1)
Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center
Ramat Gan, Israel
Related Publications (5)
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.
PMID: 16291066BACKGROUNDPecoraro 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.
PMID: 2351029BACKGROUNDPham 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.
PMID: 10834417BACKGROUNDPrompers 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.
PMID: 17093942BACKGROUNDBus 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.
PMID: 18442178BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Itzhak Siev-Ner, MD
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Orthopedic Rehabilitation department
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 22, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 27, 2016
Record last verified: 2016-01