Diabetes MellitusNCT03054454
A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure
A study testing Podiatry in people with Diabetes Mellitus and Endstage Renal Disease, run by South Tees Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Endstage Renal Disease
- What is being tested?
- Podiatry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of capacity
- Bilateral lower limb amputees
- People on dialysis who do not have diabetes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Podiatry-led Multidisciplinary Intervention to Reduce the Burden of Foot Disease in People With Diabetes and End-stage Kidney Failure
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).
Read more
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.
Read the detailed description
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 such work to address this problem anywhere in the North East and neither were aware of such an intervention anywhere in the UK.
None of the leading Consultants in the UK working in the field of diabetes-foot disease are aware of the existence of a project like this but were in agreement about the need for one.
The existing literature shows the severity of the problem but not the solution. The investigators plan to provide evidence to show an effective and cost-saving solution to reduce the burden of diabetic foot disease in people with diabetes and end-stage kidney failure People who require dialysis attend the dialysis unit 3 times a week on fixed days and in a fixed session which doesn't tend to change. People with diabetes and kidney failure on dialysis will be divided into 2 groups: a treatment group and a comparator group. The treatment group will be those that have dialysis on a Monday, Wednesday and Friday. The comparator group will be those who have dialysis on a Tuesday, Thursday and Saturday
The comparator group will continue to receive diabetes foot care using the standard model that is in existence at present (i.e. screening at GP practice, podiatry review close to home and referral to a hospital diabetes foot team when necessary)
The treatment group will be reviewed by a podiatrist while they are having dialysis. The Podiatrist will examine their feet at the first meeting and look for diabetic foot problems, if not present, make a standard assessment of the risk of diabetic foot problems developing. Further management will be guided by this assessment.
The population will fall into two groups :those without active foot problems but at high risk of developing foot problems; and those with active foot disease (e.g. foot ulcer). High risk patients without current foot problems will receive a package of treatments aimed at preventing foot ulcers (including education, removal of hard skin, foot and nail care, changes to shoes and the provision of bespoke insoles, creams and further podiatric review.
Those with active foot problems will have investigations and treatment according to individual need, which might include x-rays, tests for bacterial infection, blood tests, removal of hard skin, wound dressings and offloading. Treatments to improve blood supply to the feet and surgical removal of infected tissue might be needed. This will be lead by the podiatrist. However, other members of the diabetes foot care team (MDT) will be involved as required, using the existing weekly diabetes foot MDT meetings as a forum for discussion of the patients. Other MDT members will then also see the patients on the dialysis unit, thus providing patient-centred care.
- Conditions
- Diabetes Mellitus, Endstage Renal Disease
- Being tested
- Podiatry
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PodiatryProcedure or surgery
Podiatry treatments and care from the multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | This group will receive Podiatry treatment and care from the MDT which is the intervention group. Receives: Procedure: Podiatry |
| comparator | No intervention | This group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
number of below knee amputations attributed to diabetic foot disease
the no. of below knee amputations will be recorded in this group and compared tot he comparator group who will receive usual care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startApr 2017 (estimated)
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Simon Ashwell, Dr, Principal investigator, Trust consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054454
- Sponsor's protocol ID
- 20720171
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Podiatry-led Multidisciplinary Intervention to Reduce the Burden of Foot Disease in People With Diabetes and End-stage Kidney Failure
- ClinicalTrials.gov ID
- NCT03054454
- Acronym / sponsor ID
- 20720171
- Conditions
- Diabetes Mellitus, Endstage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Apr 2017 (estimated)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 such work to address this problem anywhere in the North East and neither were aware of such an intervention anywhere in the UK.
None of the leading Consultants in the UK working in the field of diabetes-foot disease are aware of the existence of a project like this but were in agreement about the need for one.
The existing literature shows the severity of the problem but not the solution. The investigators plan to provide evidence to show an effective and cost-saving solution to reduce the burden of diabetic foot disease in people with diabetes and end-stage kidney failure People who require dialysis attend the dialysis unit 3 times a week on fixed days and in a fixed session which doesn't tend to change. People with diabetes and kidney failure on dialysis will be divided into 2 groups: a treatment group and a comparator group. The treatment group will be those that have dialysis on a Monday, Wednesday and Friday. The comparator group will be those who have dialysis on a Tuesday, Thursday and Saturday
The comparator group will continue to receive diabetes foot care using the standard model that is in existence at present (i.e. screening at GP practice, podiatry review close to home and referral to a hospital diabetes foot team when necessary)
The treatment group will be reviewed by a podiatrist while they are having dialysis. The Podiatrist will examine their feet at the first meeting and look for diabetic foot problems, if not present, make a standard assessment of the risk of diabetic foot problems developing. Further management will be guided by this assessment.
The population will fall into two groups :those without active foot problems but at high risk of developing foot problems; and those with active foot disease (e.g. foot ulcer). High risk patients without current foot problems will receive a package of treatments aimed at preventing foot ulcers (including education, removal of hard skin, foot and nail care, changes to shoes and the provision of bespoke insoles, creams and further podiatric review.
Those with active foot problems will have investigations and treatment according to individual need, which might include x-rays, tests for bacterial infection, blood tests, removal of hard skin, wound dressings and offloading. Treatments to improve blood supply to the feet and surgical removal of infected tissue might be needed. This will be lead by the podiatrist. However, other members of the diabetes foot care team (MDT) will be involved as required, using the existing weekly diabetes foot MDT meetings as a forum for discussion of the patients. Other MDT members will then also see the patients on the dialysis unit, thus providing patient-centred care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Procedure: PodiatryThis group will receive Podiatry treatment and care from the MDT which is the intervention group. |
| comparator | No intervention | –This group will receive usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Lack of capacity
- Bilateral lower limb amputees
- People on dialysis who do not have diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PodiatryPodiatry treatments and care from the multidisciplinary team. | Procedure or surgery | intervention |
Primary outcome
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)
1 secondary outcome
number of below knee amputations attributed to diabetic foot disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Ashwell, Dr principal investigator
Trust consultant
Questions about this trial
What is this clinical trial studying?
A study testing Podiatry in people with Diabetes Mellitus and Endstage Renal Disease, run by South Tees Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Scott, Bsc Hons (01642 854237, emma.scott2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nights spent in hospital with a diabetes-related foot problem. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.