Clinical Trial: A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Podiatry-led Multidisciplinary Intervention to Reduce the Burden of Foot Disease in People With Diabetes and End-stage Kidney Failure
Brief Summary:
Observational studies clearly show that people with diabetes and end-stage kidney failure have an increased risk of foot ulceration and leg amputation. However, there is very little evidence on addressing this problem.
Diabetes foot care teams have been shown to reduce hospital admissions, length of stay and leg amputation in people with diabetes. Since their introduction at The James Cook University Hospital (JCUH) major diabetes-related leg amputation rates have fallen by 86 percent (1995 to 2010).
People with diabetes and end-stage kidney failure require haemodialysis (blood cleaning) 3 times per week for several hours each time. This time commitment makes it difficult to attend other clinical appointments. An audit at JCUH shows that this population fails to attend the normal diabetes foot services.
This project aims to reduce the incidence of foot disease in people with diabetes and end-stage kidney failure on dialysis. The investigators will set up a podiatry-led intervention within the dialysis unit to prevent and promptly treat foot disease in this population. This will involve foot risk assessment, risk reduction and treatment during dialysis. The intervention will involve diabetes consultants, podiatrists, vascular and orthopaedic surgeons . In this way the investigators hope to reduce leg amputation, hospital admission, procedures to unblock arteries and death in this high risk group.
The study will run in the dialysis unit at JCUH. Patients will be divided into two groups: those attending for dialysis on a Monday, Wednesday and Friday will form the treatment group and those attending on a Tuesday, Thursday and Saturday will continue to be managed as at present. The investigators will collect data from patient hea
Detailed Summary:
Diabetes is the largest cause of leg amputation and kidney failure; 15-20% of people with diabetes will have a foot ulcer in their lifetime, with 5-10% having an ulcer at any one time. The history of a foot ulcer in a person with diabetes increases the risk of leg amputation 2-3 fold. A person with diabetes is 23 times more likely to have a leg amputation than a person without diabetes.
The risk of having a foot ulcer is increased by another four times and the risk of leg amputation by a further eight times in people with diabetes and kidney failure on dialysis compared to those with diabetes and normal kidney function. Kidney failure in people with diabetes increased by 56% between 2006 and 2010.
Sixty per cent of people who have diabetes and a leg amputation will be dead within 5 years. Those with end stage kidney failure and a foot ulcer have an even bleaker outcome: only 50% will be alive in 2 years. This reduces to 26% following leg amputation.
An audit in 2014 of the patients attending the dialysis unit at the hospital showed that half had diabetes. Of these, half had had a foot ulcer at some point. Half of these had an ulcer at the time of the audit. Less than one quarter of those with a foot ulcer had been reviewed by the Diabetes Foot Team. National guidance states that all people with diabetes and a foot ulcer should be seen by a diabetes foot team within one working day of the ulcer being detected.
The investigators looked for evidence to show how to reduce the risk of foot problems in people with diabetes and end-stage kidney failure on dialysis but were unable to find any evidence.
Regional kidney and diabetes specialist groups have confirmed that there is no suc
Sponsor: South Tees Hospitals NHS Foundation Trust
Current Primary Outcome: Nights spent in hospital with a diabetes-related foot problem. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: number of below knee amputations attributed to diabetic foot disease [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: South Tees Hospitals NHS Foundation Trust
Dates:
Date Received: February 13, 2017
Date Started: April 2017
Date Completion: June 2017
Last Updated: February 15, 2017
Last Verified: February 2017
