Wound Healing DisorderNCT03314350
Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)
An observational study of Wound Healing Disorder and Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Wound Healing Disorder, Malnutrition
- How many people
- 517 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 31 Jan 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Geriatric patients will be recruted upon admission to the hospital.
Who may be able to join
- Age ≥ 60 years
- Informed written consent
- Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
- Life expectancy of > 3 months according to treating doctor
- Proficient in German
Who cannot join
- Lack or incapacity of informed consent
- MMSE < 24
- Life expectancy < 3 months according to assessment by the attending physician
- Short term patients (< 3 days of hospital stay)
- Lack of German language
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University Medicine, Research Group on Geriatrics
Berlin, 13347
Kristina Norman, PD Dr., +4930450565139, kristina.norman@charite.de
About this study
Official title: Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)
In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.
Read the detailed description
The investigators will determine the prevalence of impaired wound healing upon admission to the hospital as well as the incidence of new wound healing disorders during hospital stay with specific focus on malnutrition and other important nutritional parameters in geriatric patients. Therefore the investigators intend to study consecutively admitted patients both at admission and at discharge and monitor them during hospital stay.
The investigators will investigate the associations between the individual nutritional status and body composition parameters (such as sarcopenia) and WHD in geriatric patients, taking both medical variables and the frailty syndrome into account.
- Conditions
- Wound Healing Disorder, Malnutrition
- Keywords
- Geriatrics, Frailty
- Medical subject headings
- Malnutrition, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of wound healing disturbances
Number of wound healing disturbances upon admission to the hospital in General
Measured: Baseline
Secondary outcomes (9)
Nutritional Parameter
Mini Nutritional Assessment - Short Form (questionnaire)
Measured: Baseline and up to 3 weeks
Functional Parameter
Timed Up \& Go Test
Measured: Baseline and up to 3 weeks
Functional Parameter
4m-walk Test to measure gait speed
Measured: Baseline and up to 3 weeks
Functional Parameter
Lung Test to measure respiratory force
Measured: Baseline and up to 3 weeks
Strength Parameter
Hand grip strength
Measured: Baseline and up to 3 weeks
Strength Parameter
Knee extension strength
Measured: Baseline and up to 3 weeks
Frailty
Frailty Status according to Fried criteria
Measured: Baseline and up to 3 weeks
Index of quality of life
EQ-5D-5L (questionnaire) to measure quality of life
Measured: Baseline and up to 3 weeks, after 3 months and after 6 months
Body composition
Bioelectric impedance analysis
Measured: Baseline and up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Nov 2017
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
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 Wound Healing DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 517 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Norman, Charite University, Berlin, Germany
- Investigators
- Kristina Norman, PD Dr., Principal investigator, Charite Research Group on Geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314350
- Sponsor's protocol ID
- WONDER
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJ, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010 Sep;26(9):886-9. doi: 10.1016/j.nut.2010.01.016. Epub 2010 May 4.
PubMed 20444575
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)
- ClinicalTrials.gov ID
- NCT03314350
- Acronym / sponsor ID
- WONDER
- Conditions
- Wound Healing Disorder, Malnutrition
- Keywords
- Geriatrics, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 517 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 Oct 2017 (actual)
- 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.
In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.
Detailed description
The investigators will determine the prevalence of impaired wound healing upon admission to the hospital as well as the incidence of new wound healing disorders during hospital stay with specific focus on malnutrition and other important nutritional parameters in geriatric patients. Therefore the investigators intend to study consecutively admitted patients both at admission and at discharge and monitor them during hospital stay.
The investigators will investigate the associations between the individual nutritional status and body composition parameters (such as sarcopenia) and WHD in geriatric patients, taking both medical variables and the frailty syndrome into account.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Geriatric patients will be recruted upon admission to the hospital.
Key inclusion criteria (5 listed)
- Age ≥ 60 years
- Informed written consent
- Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
- Life expectancy of > 3 months according to treating doctor
- Proficient in German
Key exclusion criteria (5 listed)
- Lack or incapacity of informed consent
- MMSE < 24
- Life expectancy < 3 months according to assessment by the attending physician
- Short term patients (< 3 days of hospital stay)
- Lack of German language
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
Prevalence of wound healing disturbances
Time frame: Baseline
Number of wound healing disturbances upon admission to the hospital in General
9 secondary outcomes
Nutritional Parameter
Time frame: Baseline and up to 3 weeks
Functional Parameter
Time frame: Baseline and up to 3 weeks
Functional Parameter
Time frame: Baseline and up to 3 weeks
Functional Parameter
Time frame: Baseline and up to 3 weeks
Strength Parameter
Time frame: Baseline and up to 3 weeks
Strength Parameter
Time frame: Baseline and up to 3 weeks
Frailty
Time frame: Baseline and up to 3 weeks
Index of quality of life
Time frame: Baseline and up to 3 weeks, after 3 months and after 6 months
Body composition
Time frame: Baseline and up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 20444575Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJ, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010 Sep;26(9):886-9. doi: 10.1016/j.nut.2010.01.016. Epub 2010 May 4.
- Individual participant dataSharing planned: No
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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.
Kristina Norman, PD Dr. principal investigator
Charite Research Group on Geriatrics
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 Wound Healing Disorder and Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. 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 Germany. 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?
Contact Kristina Norman, PD Dr. (0049/30450565139, kristina.norman@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of wound healing disturbances (time frame: Baseline). 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 NCT03314350, 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 13 Nov 2019.