The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population
NCT ID: NCT04784650
Last Updated: 2023-12-29
Study Results
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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COMPLETED
NA
130 participants
INTERVENTIONAL
2021-01-31
2021-04-24
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pre-dialysis population
Pre-dialysis population, consisting both Diabetes Mellitus (DM) and non-DM patients
Pre-dialysis population
Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients
Interventions
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Pre-dialysis population
Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients
Eligibility Criteria
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Inclusion Criteria
* Minimum age of 18 years old
* Signed informed consent
Exclusion Criteria
* Unable to fill in questionnaires
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Giovanni Matricali
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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S64716
Identifier Type: -
Identifier Source: org_study_id