Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT03314350
Status:
UNKNOWN
Last Update Posted:
2019-11-13
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 517}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-11', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of wound healing disturbances', 'timeFrame': 'Baseline', 'description': 'Number of wound healing disturbances upon admission to the hospital in General'}], 'secondaryOutcomes': [{'measure': 'Nutritional Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Mini Nutritional Assessment - Short Form (questionnaire)'}, {'measure': 'Functional Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Timed Up \\& Go Test'}, {'measure': 'Functional Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': '4m-walk Test to measure gait speed'}, {'measure': 'Functional Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Lung Test to measure respiratory force'}, {'measure': 'Strength Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Hand grip strength'}, {'measure': 'Strength Parameter', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Knee extension strength'}, {'measure': 'Frailty', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Frailty Status according to Fried criteria'}, {'measure': 'Index of quality of life', 'timeFrame': 'Baseline and up to 3 weeks, after 3 months and after 6 months', 'description': 'EQ-5D-5L (questionnaire) to measure quality of life'}, {'measure': 'Body composition', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Bioelectric impedance analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geriatrics', 'Frailty'], 'conditions': ['Wound Healing Disorder', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '20444575', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatric patients will be recruted upon admission to the hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Informed written consent\n* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)\n* Life expectancy of \\> 3 months according to treating doctor\n* Proficient in German\n\nExclusion Criteria:\n\n* Lack or incapacity of informed consent\n* MMSE \\< 24\n* Life expectancy \\< 3 months according to assessment by the attending physician\n* Short term patients (\\< 3 days of hospital stay)\n* Lack of German language'}, 'identificationModule': {'nctId': 'NCT03314350', 'briefTitle': 'Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)', 'orgStudyIdInfo': {'id': 'WONDER'}}, 'contactsLocationsModule': {'locations': [{'zip': '13347', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kristina Norman, PD Dr.', 'role': 'CONTACT', 'email': 'kristina.norman@charite.de', 'phone': '+4930450565139'}], 'facility': 'Charite University Medicine, Research Group on Geriatrics', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Kristina Norman, PD Dr.', 'role': 'CONTACT', 'email': 'kristina.norman@charite.de', 'phone': '0049/30450565139'}, {'name': 'Kristina Franz, MScIS', 'role': 'CONTACT', 'email': 'kristina.franz@charite.de', 'phone': '0049/30450565137'}], 'overallOfficials': [{'name': 'Kristina Norman, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Research Group on Geriatrics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Kristina Norman', 'investigatorFullName': 'Kristina Norman', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}