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

NCT04784650 | Completed

• 1 other identifier: S64716
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer; Diabetes Mellitus; Chronic Kidney Diseases; Pre-dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• European Foot and Ankle Society (EFAS) questionnaire

  at baseline

• Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire

  at baseline

• Indication of peripheral arterial disease (PAD)

  at baseline

Study Arms (1)

Pre-dialysis population

OTHER

Pre-dialysis population, consisting both Diabetes Mellitus (DM) and non-DM patients

Other: Pre-dialysis population

Interventions

Pre-dialysis population OTHER

Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients

Pre-dialysis population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must counsel the pre-dialysis outpatient ward at UZ Leuven
• Minimum age of 18 years old
• Signed informed consent

You may not qualify if:

• Unable to understand Dutch
• Unable to fill in questionnaires

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Foot Ulcer; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Matricali

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 5, 2021
• Study Start: January 31, 2021
• Primary Completion: April 24, 2021
• Study Completion: April 24, 2021
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)