Nutrition in People With a Lower Limb Amputation

NCT ID: NCT05747066

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-21

Study Completion Date

2024-09-09

Brief Summary

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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)?

Detailed Description

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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.

Conditions

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Diet, Food, and Nutrition Nutrition Disorders Amputation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Undergoing or recently (i.e., within the last seven weeks) having undergone a major dysvascular lower limb amputation (i.e., Syme amputation or more proximal level)
* 18 years or older
* Able to collaborate

Exclusion Criteria

* Requiring re-amputation
* Severe malabsorption disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan HB Geertzen

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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Treant Zorggroep

Emmen, Drenthe, Netherlands

Site Status

Isala Zwolle

Zwolle, Overijssel, Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status

Martini Ziekenhuis Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Ommelander Ziekenhuis Groep

Scheemda, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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10929

Identifier Type: -

Identifier Source: org_study_id

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