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

NCT01089829 | Unknown DMC

• 1 other identifier: SRiley&NJones
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Keywords

CKD; Foot Ulceration; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (1)

• 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.

  4 years

Study Arms (2)

CKD Stage 4

eGFR \<30

Other: Foot examination

CKD Stage 5

Receiving Haemodialysis or Peritoneal dialysis therapy

Other: Foot examination

Interventions

Foot examination OTHER

Non-invasive neurological sensory testing Non-invasive doppler assessment of peripheral arterial system

Also known as: CKD Stage 4 interventions at baseline, 12 & 24 months, CKD Stage 5 interventions at baseline, 6 & 12 months

CKD Stage 4; CKD Stage 5

Eligibility Criteria

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

You may qualify if:

• Stage 4/5 Chronic Kidney Disease (EGFR \<30ml/min) Over 18 years of age

You may not qualify if:

• CKD stage 1-3 (eGFR \>31)
• Inability or refusal to give informed consent
• Life expectancy \< 6 months

Sponsors & Collaborators

• Cardiff University: lead
• Podiatry Department, Cardiff & Vale University Health Board: collaborator
• School of Health Sciences, UWIC: collaborator
• Institute of Nephrology, Cardiff & Vale University Health Board: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Foot Ulcer; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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; 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

Study Officials

• Ian DR Mathieson

  School of Health Sciences, UWIC

  STUDY DIRECTOR

Central Study Contacts

Stephen Riley, Dr

CONTACT

02920748467; rileysg@cardiff.ac.uk

Nia Jones

CONTACT

07786983288; niajudithjones@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: March 19, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 19, 2010

Record last verified: 2010-01

Locations

GB (1)