Risk Factors for Foot Ulceration in the Chronic Kidney Disease (CKD) Population

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2010 by Cardiff University
Sponsor:
Collaborators:
Podiatry Department, Cardiff & Vale University Health Board
School of Health Sciences, UWIC
Institute of Nephrology, Cardiff & Vale University Health Board
Information provided by:
Cardiff University
ClinicalTrials.gov Identifier:
NCT01089829
First received: February 4, 2010
Last updated: March 18, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 4 interventions at baseline, 12 & 24 months
  • CKD Stage 5 interventions at baseline, 6 & 12 months
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:
  • CKD Stage 4 interventions at baseline, 12 & 24 months
  • CKD Stage 5 interventions at baseline, 6 & 12 months

  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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089829

Contacts
Contact: Stephen Riley, Dr 02920748467 ext 8467 rileysg@cardiff.ac.uk
Contact: Nia Jones 07786983288 niajudithjones@hotmail.com

Locations
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   
Sponsors and Collaborators
Cardiff University
Podiatry Department, Cardiff & Vale University Health Board
School of Health Sciences, UWIC
Institute of Nephrology, Cardiff & Vale University Health Board
Investigators
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
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014