Diabetes Mellitus Type 2KybootNCT02451722
Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear
A study testing Kyboot shoes in people with Diabetes Mellitus Type 2 and Sensory Neuropathy, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2, Sensory Neuropathy, Foot Ulcer, Diabetic
- What is being tested?
- Kyboot shoes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center
Ramat Gan
About this study
Official title: 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.
Read the 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.
- Being tested
- Kyboot shoes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyboot shoesDevice
Also called Kybun shoe
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Active comparator | Kyboot shoes will be administered to the healthy subjects.
Pressure distribution and gait parameters will be recorded in comparison with their normal footwear. Receives: Device: Kyboot shoes |
| Diabetic patients | Active comparator | Kyboot shoes will be administered to the diabetic patients.
Pressure distribution and gait parameters will be recorded in comparison with their normal footwear. Receives: Device: Kyboot shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Peak Pressure
The pressure distribution will be measured by in-sole pressure sensors.
Measured: 1 day
Secondary outcomes (1)
Comfort of wear
Comfort of wear will be evaluated with the help of a questionnaire
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Kybun AG
- Responsible party
- Principal investigator, Dr. Itzhak Siev-Ner, Sheba Medical Center
- Investigators
- Itzhak Siev-Ner, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451722
- Sponsor's protocol ID
- SHEBA-2053-15-SMC
- Acronym
- Kyboot
- Status last verified
- Jan 2016
- First submitted
- 20 May 2015
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16291066Pecoraro 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.
PubMed 2351029Pham 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.
PubMed 10834417Prompers 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.
PubMed 17093942Bus 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.
PubMed 18442178
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear in Diabetic Patients and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02451722
- Acronym / sponsor ID
- Kyboot / SHEBA-2053-15-SMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Kybun AG
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Active comparator | Device: Kyboot shoesKyboot 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 comparator | Device: Kyboot shoesKyboot shoes will be administered to the diabetic patients. Pressure distribution and gait parameters will be recorded in comparison with their normal footwear. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kyboot shoesAlso: Kybun shoeThe 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 | Device | Diabetic patients, Healthy subjects |
Primary outcome
Reduction of Peak Pressure
Time frame: 1 day
The pressure distribution will be measured by in-sole pressure sensors.
1 secondary outcome
Comfort of wear
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 16291066Boulton 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.
- Background: PubMed 2351029Pecoraro 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.
- Background: PubMed 10834417Pham 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.
- Background: PubMed 17093942Prompers 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.
- Background: PubMed 18442178Bus 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.
- The company providing the Kyboot shoeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itzhak Siev-Ner, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kyboot shoes in people with Diabetes Mellitus Type 2 and Sensory Neuropathy, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Peak Pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451722, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.