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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
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
South Tees Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Endstage Renal Disease Procedure: Podiatry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: intervention
This group will receive Podiatry treatment and care from the MDT which is the intervention group.
Procedure: Podiatry
Podiatry treatments and care from the multidisciplinary team.

No Intervention: comparator
This group will receive usual care



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lack of capacity
  • Bilateral lower limb amputees
  • People on dialysis who do not have diabetes

Information from the National Library of Medicine

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


Contacts
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Contact: Emma Scott, Bsc Hons 01642 854237 emma.scott2@nhs.net
Contact: Simon Ashwell, Dr 01642 875722 simon.ashwell@stees.nhs.uk

Sponsors and Collaborators
South Tees Hospitals NHS Foundation Trust
Boehringer Ingelheim
Investigators
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Principal Investigator: Simon Ashwell, Dr Trust consultant
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Responsible Party: South Tees Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03054454    
Other Study ID Numbers: 20720171
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot Diseases
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Musculoskeletal Diseases
Skin Diseases