Changes in Elasticity Duo to Pressure Ulcers in ButtocksNCT03041922
Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing
An observational study of Changes in Elasticity Duo to Pressure Ulcers in Buttocks, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting positions by using ultrasound device. the elasticity of fat and muscle tissues will be measured. May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to continuous sitting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Changes in Elasticity Duo to Pressure Ulcers in Buttocks
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Jul 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gender: all Age Limits: above 18 years old Healthy volunteers
Who may be able to join
- -
Who cannot join
- People with neurological deficit
- people with diabetes
- people with a BMI above 29.9 or below 18.5
- pregnant women
- people with bedsores
- mental incompetence.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Dr. Leonid Chervinsky
Afula, 1834111
Leonid Chervinsky, Doctor, 04-6494063, leonid_ch@clalit.org.il
Ruba Mansour, BSC, 0527430824, rubama@clalit.org.il
About this study
Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting positions by using ultrasound device. the elasticity of fat and muscle tissues will be measured.
May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to continuous sitting.
Read the detailed description
The purpose of the current new research is to check whether Ultrasound device can be used as a tool for assessing the elasticity of the soft tissues in buttocks and measuring the elasticity of these tissues with and without bearing weight on a healthy population to set standards of normal values.
The far purpose of the research is to use ultrasound device for predicting the development of pressure ulcers.
Population and Methods: In this study, Up to 15 healthy people will participate. Each participant will pass ultrasound scans of the buttocks, lying down and sitting on a chair designed for the purpose of research and this after signing an informed consent form.
The process:
- The participant lies on his stomach on a bed to determine the location of the muscle that will be marked by a marker.By ultrasound, the investigator measures the thickness of fat and muscle tissues between the Ischial Tuberosity (ITs) and the skin.
- The participant sits without bearing weight on a chair built for this study, the seat is constructed from five straps. Non-weight bearing test is when the straps are far from the test area, the transducer is placed on the marked place, thickness and elasticity of muscle tissue and fat will be measured.
- The participant sits with bearing weight on the chair. weight bearing test is when the straps are close to the test area , the transducer is placed on the marked place, thickness and elasticity of muscle tissue and fat will be measured.
After measuring the elasticity of the soft tissues,the data will be analyzed in order to define ranges of differences between elasticity with and without weight bearing.
- Keywords
- Elastography, Buttocks, Ultrasound, Soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Every participant passes one ultrasound exam for soft tissues in buttocks in order to measure the elasticity of soft tissues in sitting and lying down positions. This kind of exam may help to predict a development in pressure ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity values to be measured by ultrasound device
Elastography software in ultrasound device enable to measure the elasticity of soft tissues in human body in kilo pascal units.
Measured: Each exam takes about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Elasticity Duo to Pressure Ulcers in ButtocksStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEONID CHERVINSKY, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041922
- Sponsor's protocol ID
- 0026-16-CMC
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing
- ClinicalTrials.gov ID
- NCT03041922
- Acronym / sponsor ID
- 0026-16-CMC
- Keywords
- Elastography, Buttocks, Ultrasound, Soft tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 3 Feb 2017 (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.
Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting positions by using ultrasound device. the elasticity of fat and muscle tissues will be measured.
May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to continuous sitting.
Detailed description
The purpose of the current new research is to check whether Ultrasound device can be used as a tool for assessing the elasticity of the soft tissues in buttocks and measuring the elasticity of these tissues with and without bearing weight on a healthy population to set standards of normal values.
The far purpose of the research is to use ultrasound device for predicting the development of pressure ulcers.
Population and Methods: In this study, Up to 15 healthy people will participate. Each participant will pass ultrasound scans of the buttocks, lying down and sitting on a chair designed for the purpose of research and this after signing an informed consent form.
The process:
- The participant lies on his stomach on a bed to determine the location of the muscle that will be marked by a marker.By ultrasound, the investigator measures the thickness of fat and muscle tissues between the Ischial Tuberosity (ITs) and the skin.
- The participant sits without bearing weight on a chair built for this study, the seat is constructed from five straps. Non-weight bearing test is when the straps are far from the test area, the transducer is placed on the marked place, thickness and elasticity of muscle tissue and fat will be measured.
- The participant sits with bearing weight on the chair. weight bearing test is when the straps are close to the test area , the transducer is placed on the marked place, thickness and elasticity of muscle tissue and fat will be measured.
After measuring the elasticity of the soft tissues,the data will be analyzed in order to define ranges of differences between elasticity with and without weight bearing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | –Every participant passes one ultrasound exam for soft tissues in buttocks in order to measure the elasticity of soft tissues in sitting and lying down positions. This kind of exam may help to predict a development in pressure ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gender: all Age Limits: above 18 years old Healthy volunteers
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- People with neurological deficit
- people with diabetes
- people with a BMI above 29.9 or below 18.5
- pregnant women
- people with bedsores
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elasticity values to be measured by ultrasound device
Time frame: Each exam takes about 30 minutes
Elastography software in ultrasound device enable to measure the elasticity of soft tissues in human body in kilo pascal units.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- reasearch- In Vivo Muscle Stiffening Under Bone Compression Promotes Deep Pressure SoresLink provided by the sponsor.
- research: The relationship between pressure ulcer incidence and buttock-seat cushion interface pressure in at-risk elderly wheelchair users.Link provided by the sponsor.
- research: Use of weight-bearing MRI for evaluating wheelchair cushions based on internal soft-tissue deformations under ischial tuberositiesLink provided by the sponsor.
- research: The effect of mechanical strains in soft tissues of the shoulder during load carriageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Changes in Elasticity Duo to Pressure Ulcers in Buttocks, run by HaEmek Medical Center, Israel 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity values to be measured by ultrasound device (time frame: Each exam takes about 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.