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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03314350
Other study ID # WONDER
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date January 31, 2021

Study information

Verified date November 2019
Source Charite University, Berlin, Germany
Contact Kristina Norman, PD Dr.
Phone 0049/30450565139
Email kristina.norman@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 517
Est. completion date January 31, 2021
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charite University Medicine, Research Group on Geriatrics Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of wound healing disturbances Number of wound healing disturbances upon admission to the hospital in General Baseline
Secondary Nutritional Parameter Mini Nutritional Assessment - Short Form (questionnaire) Baseline and up to 3 weeks
Secondary Functional Parameter Timed Up & Go Test Baseline and up to 3 weeks
Secondary Functional Parameter 4m-walk Test to measure gait speed Baseline and up to 3 weeks
Secondary Functional Parameter Lung Test to measure respiratory force Baseline and up to 3 weeks
Secondary Strength Parameter Hand grip strength Baseline and up to 3 weeks
Secondary Strength Parameter Knee extension strength Baseline and up to 3 weeks
Secondary Frailty Frailty Status according to Fried criteria Baseline and up to 3 weeks
Secondary Index of quality of life EQ-5D-5L (questionnaire) to measure quality of life Baseline and up to 3 weeks, after 3 months and after 6 months
Secondary Body composition Bioelectric impedance analysis Baseline and up to 3 weeks
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