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Clinical Trials/NCT04784650
NCT04784650
Completed
Not Applicable

The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population: a Cross-sectional Study

Universitaire Ziekenhuizen KU Leuven1 site in 1 country130 target enrollmentJanuary 31, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Ulcer
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
130
Locations
1
Primary Endpoint
Presence of foot problems (no = 0, yes = 1)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2021
End Date
April 24, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Presence of foot problems (no = 0, yes = 1)

Time Frame: at baseline

To describe the prevalence and type of foot complaints/problems in a pre-dialysis population during foot assessment

Secondary Outcomes

  • Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire(at baseline)
  • European Foot and Ankle Society (EFAS) questionnaire(at baseline)
  • Indication of peripheral arterial disease (PAD)(at baseline)

Study Sites (1)

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