The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population
Primary Purpose
Foot Ulcer, Diabetes Mellitus, Chronic Kidney Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pre-dialysis population
Sponsored by
About this trial
This is an interventional diagnostic trial for Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- Subjects must counsel the pre-dialysis outpatient ward at UZ Leuven
- Minimum age of 18 years old
- Signed informed consent
Exclusion Criteria:
- Unable to understand Dutch
- Unable to fill in questionnaires
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pre-dialysis population
Arm Description
Pre-dialysis population, consisting both Diabetes Mellitus (DM) and non-DM patients
Outcomes
Primary Outcome Measures
Presence of foot problems (no = 0, yes = 1)
To describe the prevalence and type of foot complaints/problems in a pre-dialysis population during foot assessment
Secondary Outcome Measures
European Foot and Ankle Society (EFAS) questionnaire
To explore the possible risk factors that cause particular foot complaints/problems and to formulate suggestions to create a future prevention program to avoid, where possible, foot problems
Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire
To evaluate the repercussion of these foot problems on the general health status and the quality of life of the patients
Indication of peripheral arterial disease (PAD)
Patient records will be screened for available medical imaging (in any form) of the blood vessels.
Full Information
NCT ID
NCT04784650
First Posted
March 1, 2021
Last Updated
March 4, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04784650
Brief Title
The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population
Official Title
The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population: a Cross-sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetes mellitus is one of the main causes of chronic kidney disease (CKD) and an increased risk of foot complications is seen in patients suffering from both DM and CKD. CKD and DM patients share a trilogy of risk factors that contribute to the development of foot ulcers. This trilogy consists of peripheral arterial disease (PAD), neuropathy and an increased susceptibility to infection with an impaired wound healing. Additionally, almost one quarter of adults with CKD have to cope with depression.
The aim of our study is to determine the prevalence and types of foot problems in a pre-dialysis population, consisting of both DM and non-DM patients. If possible, risk factors will be determined. The detrimental effects of poor kidney function and foot problems on the quality of life and the general health status will be analyzed. A higher prevalence of PAD, peripheral neuropathy and DM are expected in patients with foot problems compared to those without.
Detailed Description
Plenty of research has been published regarding the prevalence of foot ulcers in a diabetes mellitus (DM) population. Zhang et al. concluded that foot ulceration is prevalent in 6,3% of DM patients worldwide. Moreover, diabetes mellitus is one of the main causes of chronic kidney disease (CKD) and an increased risk of foot complications is seen in patients suffering from both DM and CKD. Furthermore, dialysis treatment is also associated with a higher probability of foot ulceration.
According to Ndip et al., CKD and DM patients share a trilogy of risk factors that contribute to the development of foot ulcers. This trilogy consists of peripheral arterial disease (PAD), neuropathy and an increased susceptibility to infection with an impaired wound healing. Both diabetic and non-diabetic CKD patients have a high risk for peripheral neuropathy, creating a decreased sensation in the feet. This makes them more vulnerable for minor trauma, leading to the development of foot ulcers. These often precede more serious foot complications like infections and amputations, which have a great impact on the morbidity and mortality of the patient. They also cause a major financial load for the healthcare system.
Additionally, almost one quarter of adults with CKD have to cope with depression. This is independently associated with a reduced quality of life in a pre-dialysis population. The quality of life is also impaired by the presence of PAD, peripheral neuropathy and foot problems. Unfortunately, patients can be so overwhelmed by their renal disease that they avoid education and self-care, which can lead to even more complications and health costs.
In UZ Leuven, patients with a severe loss of kidney function (down to 25 percent or less of the normal function) are taken up in the pre-dialysis program. In contrast to DM and dialysis patients, there is a paucity of data about the prevalence of different foot problems in a pre-dialysis population. Freeman et al. performed one of the few studies that also include non-DM CKD patients. Hereby, a similar frequency of foot ulcers was found in CKD patients as in DM patients. However, an important limitation of the study is the small sample group size, so further research is needed. As CKD in stages 3 to 5 may affect approximately 10% of the global population, it is important to learn more about the different foot complaints that occur in these patients.
The aim of our study is to determine the prevalence and types of foot problems in a pre-dialysis population, consisting of both DM and non-DM patients. If possible, risk factors will be determined. The detrimental effects of poor kidney function and foot problems on the quality of life and the general health status will be analyzed. A higher prevalence of PAD, peripheral neuropathy and DM are expected in patients with foot problems compared to those without.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetes Mellitus, Chronic Kidney Diseases, Pre-dialysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-dialysis population
Arm Type
Other
Arm Description
Pre-dialysis population, consisting both Diabetes Mellitus (DM) and non-DM patients
Intervention Type
Other
Intervention Name(s)
Pre-dialysis population
Intervention Description
Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients
Primary Outcome Measure Information:
Title
Presence of foot problems (no = 0, yes = 1)
Description
To describe the prevalence and type of foot complaints/problems in a pre-dialysis population during foot assessment
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
European Foot and Ankle Society (EFAS) questionnaire
Description
To explore the possible risk factors that cause particular foot complaints/problems and to formulate suggestions to create a future prevention program to avoid, where possible, foot problems
Time Frame
at baseline
Title
Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire
Description
To evaluate the repercussion of these foot problems on the general health status and the quality of life of the patients
Time Frame
at baseline
Title
Indication of peripheral arterial disease (PAD)
Description
Patient records will be screened for available medical imaging (in any form) of the blood vessels.
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must counsel the pre-dialysis outpatient ward at UZ Leuven
Minimum age of 18 years old
Signed informed consent
Exclusion Criteria:
Unable to understand Dutch
Unable to fill in questionnaires
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population
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