A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure
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|ClinicalTrials.gov Identifier: NCT03054454|
Recruitment Status : Unknown
Verified February 2017 by South Tees Hospitals NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : February 15, 2017
Last Update Posted : February 16, 2017
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 health care records looking in particular at leg amputations, hospital admissions due to foot problems, foot surgery and operations to unblock arteries.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Endstage Renal Disease||Procedure: Podiatry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Podiatry-led Multidisciplinary Intervention to Reduce the Burden of Foot Disease in People With Diabetes and End-stage Kidney Failure|
|Estimated Study Start Date :||April 2017|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||June 2017|
Active Comparator: intervention
This group will receive Podiatry treatment and care from the MDT which is the intervention group.
Podiatry treatments and care from the multidisciplinary team.
No Intervention: comparator
This group will receive usual care
- Nights spent in hospital with a diabetes-related foot problem. [ Time Frame: 1 year ]Nights spent in hospital with a diabetes-related foot (below ankle) problem (ulceration, cellulitis, foot pain, swelling, foot infection/ osteomyelitis, necrosis, gangrene, blister, ischaemia, fracture)
- number of below knee amputations attributed to diabetic foot disease [ Time Frame: 1 year ]the no. of below knee amputations will be recorded in this group and compared tot he comparator group who will receive usual care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054454
|Contact: Emma Scott, Bsc Hons||01642 email@example.com|
|Contact: Simon Ashwell, Dr||01642 firstname.lastname@example.org|
|Principal Investigator:||Simon Ashwell, Dr||Trust consultant|