Pressure Ulcer Lesions (Grade 2 or More)NCT00262444
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
A study testing Different turning frequencies in people with Pressure Ulcer Lesions (Grade 2 or More), run by University Ghent at 1 site in Belgium.
Trial summary
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Lesions (Grade 2 or More)
- What is being tested?
- Different turning frequencies
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2003to May 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-blanchable erythema above a bony prominence
- Informed consent
Who cannot join
- Pressure ulcers grade 3 or 4
- Turning contra-indicated based on medical grounds
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Read the detailed description
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
- Conditions
- Pressure Ulcer Lesions (Grade 2 or More)
- Being tested
- Different turning frequencies
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different turning frequenciesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pressure ulcers
Measured: during 5 weeks
Time to develop pressure ulcers
Secondary outcomes (1)
Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startSep 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure Ulcer Lesions (Grade 2 or More)Studies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Distrac
- Investigators
- Tom Defloor, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262444
- Sponsor's protocol ID
- 2003/084
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.
PubMed 17184374
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00262444
- Acronym / sponsor ID
- 2003/084
- Conditions
- Pressure Ulcer Lesions (Grade 2 or More)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Distrac
- Study start
- Sep 2003
- Study completion
- May 2005 (actual)
- First posted
- 6 Dec 2005 (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 difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Detailed description
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-blanchable erythema above a bony prominence
- Informed consent
Key exclusion criteria (2 listed)
- Pressure ulcers grade 3 or 4
- Turning contra-indicated based on medical grounds
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 |
|---|---|---|
| Different turning frequencies | Procedure or surgery | – |
Primary outcome
Incidence of pressure ulcers
Time frame: during 5 weeks
Time to develop pressure ulcers
1 secondary outcome
Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
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 28 Dec 2007.
- Results publication: PubMed 17184374Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.
- Website of the University GhentLink provided by the sponsor.
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.
Tom Defloor, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different turning frequencies in people with Pressure Ulcer Lesions (Grade 2 or More), run by University Ghent at 1 site in Belgium.
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 2 inclusion and 2 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 28 Dec 2007. 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 Belgium. 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?
Incidence of pressure ulcers (time frame: during 5 weeks). The study lists 2 primary outcomes in all. 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 NCT00262444, which also lists 1 linked publication.
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 28 Dec 2007; AzTrials last refreshed its copy on 6 Nov 2026.