Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-01-23
Brief Title:
Nutrition in People With a Lower Limb Amputation
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Nutritional Intake Nutritional Status and Physical Activity Level in People Who Have Undergone a Major Dysvascular Lower Limb Amputation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this prospective longitudinal observational cohort study is to determine the nutritional intake nutritional status and physical activity level in people who have undergone a major dysvascular lower limb amputation LLA at different moments post-LLA during hospital admission several days post-LLA and at 5 weeks 6 months and 9 months post-LLA The main questions this study aims to answer are
What is the nutritional intake nutritional status and physical activity level at different moments post-LLA
What is the association between nutritional intake and physical activity level and nutritional status
What is the association between nutritional intake nutritional status and physical activity level and clinical outcomes mortality wound healing quality of life physical functioning
What is the nutritional intake nutritional status and physical activity level at different moments post-LLA
What is the association between nutritional intake and physical activity level and nutritional status
What is the association between nutritional intake nutritional status and physical activity level and clinical outcomes mortality wound healing quality of life physical functioning
Detailed Description:
People requiring an LLA are at high risk for adverse clinical outcomes Undernutrition and low physical activity level may affect clinical outcomes negatively However little is known about the nutritional intake nutritional status and physical activity level in the LLA population and their association with clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None