Risk Factors for Foot Ulceration in the Chronic Kidney Disease (CKD) Population
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Foot ulceration is a risk factor that has been associated with early death in patients with chronic kidney disease. Little is known about the relationship between these risk factors that develop in patients with kidney failure and the onset of lower limb threatening foot ulcers.
Diabetes is a major cause of both kidney disease and foot ulceration; however a previous study reported that a significant proportion of kidney failure patients on haemodialysis treatment without a diagnosis of diabetes also had these risk factors that could lead to foot ulceration.
The aim of this study will be to identify these risk factors associated with lower limb threatening disease in patients with advanced kidney failure. In addition a robust screening tool will be developed to address the reliability and validity of current screening methods deemed to be gold standard in the assessment of diabetic foot disease in this Chronic Kidney Disease population.
It is important to follow the progression of these risk factors as the kidney failure worsens. The study also intends to screen patients as they start dialysis treatment and follow their progress with respect to risk factors known to predispose to foot ulceration over their first year of treatment. The proposed outcome from this study is to develop a strategy to identify patients with kidney failure that are at risk of foot ulceration and intervene at an early point to prevent the life threatening complications associated foot disease.
| Condition | Intervention |
|---|---|
|
Chronic Kidney Disease |
Other: Foot examination |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Pathological Relationships Between Chronic Kidney Disease (CKD)and the Development of Lower Limb Threatening Complications |
- The primary outcome of the study is to identify the neurovascular risk factors for foot ulceration as renal function declines, and to develop a suitable foot protection programme for CKD patients. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- The secondary outcome measure is to identify whether dialysis modality choice influence foot ulcer development and should this be used to inform patient choice of dialysis. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
CKD Stage 4
eGFR <30
|
Other: Foot examination
Non-invasive neurological sensory testing Non-invasive doppler assessment of peripheral arterial system Other Names:
|
|
CKD Stage 5
Receiving Haemodialysis or Peritoneal dialysis therapy
|
Other: Foot examination
Non-invasive neurological sensory testing Non-invasive doppler assessment of peripheral arterial system Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
It is proposed to identify patients with CKD level 4 (renal function at between 15 and 30% of normal)in the Nephrology clinics at University Hospital of Wales, Cardiff. It is this group of patients that are most at risk of progression of renal disease towards end stage and subsequent need for dialysis.
A proportion of the patients will be identified from the pre-dialysis clinics that are due to commence dialysis imminently. It is this group of patients that will used to examine the specific effects of dialysis modality on risk factors for foot ulceration The directorate of Nephrology and Transplantation in Cardiff has 450 haemodialysis patients, 140 peritoneal dialysis (CAPD) patients, and around 400 CKD level 4 patients. Approximately 100 new patients commence dialysis each year of which 35 will start CAPD and the rest haemodialysis.
Inclusion Criteria:
- Stage 4/5 Chronic Kidney Disease (EGFR <30ml/min) Over 18 years of age
Exclusion Criteria:
- CKD stage 1-3 (eGFR >31)
- Inability or refusal to give informed consent
- Life expectancy < 6 months
Contacts and Locations| Contact: Stephen Riley, Dr | 02920748467 ext 8467 | rileysg@cardiff.ac.uk |
| Contact: Nia Jones | 07786983288 | niajudithjones@hotmail.com |
| United Kingdom | |
| University Hospital of Wales | Not yet recruiting |
| Cardiff, United Kingdom, CF14 4XW | |
| Contact: Stephen Riley, Dr 02920748467 ext 8467 rileysg@cardiff.ac.uk | |
| Contact: Nia Jones 07786983288 niajudithjones@hotmail.com | |
| Study Director: | Ian DR Mathieson | School of Health Sciences, UWIC |
More Information
No publications provided
| Responsible Party: | Dr Stephen Riley, Senior Lecturer and Hon Consultant Nephrologist |
| ClinicalTrials.gov Identifier: | NCT01089829 History of Changes |
| Other Study ID Numbers: | SRiley&NJones |
| Study First Received: | February 4, 2010 |
| Last Updated: | March 18, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Cardiff University:
|
CKD Foot Ulceration Diabetes |
Additional relevant MeSH terms:
|
Kidney Diseases Foot Ulcer Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases |
Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Renal Insufficiency |
ClinicalTrials.gov processed this record on May 21, 2013