A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure
A Podiatry-led Multidisciplinary Intervention to Reduce the Burden of Foot Disease in People With Diabetes and End-stage Kidney Failure
1 other identifier
interventional
32
0 countries
N/A
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 health care records looking in particular at leg amputations, hospital admissions due to foot problems, foot surgery and operations to unblock arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Apr 2017
Shorter than P25 for not_applicable diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFebruary 16, 2017
February 1, 2017
1 month
February 13, 2017
February 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Nights spent in hospital with a diabetes-related foot problem.
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)
1 year
Secondary Outcomes (1)
number of below knee amputations attributed to diabetic foot disease
1 year
Study Arms (2)
intervention
ACTIVE COMPARATORThis group will receive Podiatry treatment and care from the MDT which is the intervention group.
comparator
NO INTERVENTIONThis group will receive usual care
Interventions
Eligibility Criteria
You may qualify if:
- Diabetes Type 1 2, secondary or MODY
- End-stage renal failure (CKD stage 5)
- Routinely attending the dialysis unit at The James Cook University Hospital for regular dialysis
You may not qualify if:
- Lack of capacity
- Bilateral lower limb amputees
- People on dialysis who do not have diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Tees Hospitals NHS Foundation Trustlead
- Boehringer Ingelheimcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Ashwell, Dr
Trust consultant
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2017
First Posted
February 15, 2017
Study Start
April 1, 2017
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
February 16, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share