Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04784650 |
| Other study ID # |
S64716 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2021 |
| Est. completion date |
April 24, 2021 |
Study information
| Verified date |
December 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
