Pressure UlcersNCT00351312
Creation of a Pressure Reducing Areas in Socks
A study testing special socks in people with Pressure Ulcers, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- special socks
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Jun 2006
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- foot deformity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Motion Analysis Laboratory, Sheba Medical Center
Tel Litwinsky, 52621
About this study
Official title: Evaluation of Foot Pressure in Volunteers Wearing Socks Weaved With Pressure Reducing Soles
Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.
Read the detailed description
Increased pressure in weight bearing areas of the foot, especially in insensate feet may lead to the development of pressure sore. The creation of socks with pressure relieving areas by special weaving technique may prevent the development of these complications.
Three (3) volunteers will be examined walking on a Tekscan pressure mat, barefoot and then wearing socks weaved in a new technique, from cotton, nylon and acrilan.
- Conditions
- Pressure Ulcers
- Being tested
- special socks
- Keywords
- Pressure ulcers, socks, foot pressure
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
special socksDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Uri Givon, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351312
- Sponsor's protocol ID
- SHEBA-06-4163-UG-CTIL
- Status last verified
- Jul 2006
- First submitted
- 11 Jul 2006
- Last updated
- 12 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Foot Pressure in Volunteers Wearing Socks Weaved With Pressure Reducing Soles
- ClinicalTrials.gov ID
- NCT00351312
- Acronym / sponsor ID
- SHEBA-06-4163-UG-CTIL
- Conditions
- Pressure Ulcers
- Keywords
- Pressure ulcers, socks, foot pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2006
- Study completion
- Jun 2006
- First posted
- 12 Jul 2006 (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.
Evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.
Detailed description
Increased pressure in weight bearing areas of the foot, especially in insensate feet may lead to the development of pressure sore. The creation of socks with pressure relieving areas by special weaving technique may prevent the development of these complications.
Three (3) volunteers will be examined walking on a Tekscan pressure mat, barefoot and then wearing socks weaved in a new technique, from cotton, nylon and acrilan.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- foot deformity
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 |
|---|---|---|
| special socks | Device | – |
Primary outcome
Pressure measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2006.
Related trials for Pressure Ulcers
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
Not yet recruiting
The Effect Of Low-Fidelity Simulation Education Pressure Injuries
Nursing Education Research, Simulation Based Learning
Not yet recruiting
Evaluation of the Effectiveness of Vision Care in Preventing Falls in Hospitalized Patients
Falls, Ulcer, Pressure
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.
Uri Givon, 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 special socks in people with Pressure Ulcers, 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 1 inclusion and 1 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 12 Jul 2006. 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?
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?
Pressure measurement. 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 12 Jul 2006.