The Prevalence of Foot Complaints/Problems and Ulcers in a Pre-dialysis Population

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Foot Ulcer; Chronic Kidney Diseases; Pre-dialysis
• Intervention / Treatment: Other: Pre-dialysis population

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pre-dialysis population; Pre-dialysis population, consisting both Diabetes Mellitus (DM) and non-DM patients	Other: Pre-dialysis population; Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline
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	at baseline
Indication of peripheral arterial disease (PAD)	Patient records will be screened for available medical imaging (in any form) of the blood vessels.	at baseline

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Giovanni Matricali, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): April 24, 2021
• Study Completion (Actual): April 24, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Urologic Diseases; Disease Attributes; Leg Ulcer; Skin Ulcer; Foot Diseases; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Foot Ulcer; Ulcer; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: S64716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No