Foot Ulceration in DiabetesESPNCT00729456
Evaluation of Education in the Secondary Prevention of Foot Ulceration in Diabetes
A study testing Education in people with Foot Ulceration in Diabetes, run by Nottingham University Hospitals NHS Trust at 3 sites in United Kingdom.
Trial summary
This study was an attempt to confirm the results of an earlier experiment in which the benefit of an education programme was assessed in a group of people with diabetes complicated by ulceration of the foot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulceration in Diabetes
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2003to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes and an ulcer of the foot which had been managed at one of the three participating centres and which had healed within the preceding 3 months, leaving them ulcer-free for at least 28 days
Who cannot join
- Living in institutional care
- Documented history of dementia
- Other serious medical problems
- Non-English speaking and without an English-speaking carer
- Lived more than 50 miles from the centre
- Involved in another study
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Derbyshire Royal Infirmary
Derbyshire, DE1 2QY
Nottingham City Hospital
Nottingham, NG5 1PB
Queens Medical Centre
Nottingham, NG7 2UH
About this study
This study was an attempt to confirm the results of an earlier experiment in which the benefit of an education programme was assessed in a group of people with diabetes complicated by ulceration of the foot. Foot ulcers are the source of considerable suffering and cost and carry a high risk of amputation: they are difficult to heal and approximately 40% recur in the first 12 months. The earlier experiment (published by Malone and colleagues in 1989) indicated that a single hour-long education session appeared to lead to a three-fold reduction in the numbers of ulcers which recurred after successful treatment. It was not possible to confirm these findings in the present study in which patients from three specialist clinics in Nottingham and Derby, UK, were allocated either to receive a one-to-one, individually targeted, education programme in the own home (and reinforced after one month by a telephone call), or to receive usual care. The group who received the education reported better recommended foot care behaviour (intended to minimise the risk of injury) at 12 months but despite this, there was no difference between the two groups in the percentage who suffered either a new ulcer (41% education versus 41% usual care) or amputation (10% and 11%, respectively). While the benefit of education is undeniable in general, it was not possible to show that this particular teaching session had an impact on the occurrence of new disease in this group of patients.
Read the detailed description
This was a randomised controlled trial of the effect over 12 months of a one-to-one educational package designed to improve foot care behaviour in a group of patients at the highest risk of new foot disease: those with a recently healed ulcer. The primary outcome was the incidence of new ulceration at 12 months. Secondary outcomes included self-reported footcare behaviour, new ulceration at 6 months, amputation (major or minor) at 12 and 6 months, and measures of well-being (SF36; Diabetic Foot Ulcer Scale, DFS short-form). The educational intervention was based on the content of the International Consensus on the Diabetic Foot, 2003, was modified following discussion with a focus group of former ulcer sufferers, and included graphic images of different forms of foot disease. Although structured, the information was targeted in discussion to the individual's circumstances, and was delivered one-to-one in the patient's own home by a single health care professional. It was reinforced after one month by a semi-structured phone conversation with the same educator. Outcomes were determined by postal questionnaire, backed up with reminders and phone calls when necessary, as well questionnaires sent to GP staff and by searching hospital records. Foot care behaviour was assessed at 12 months using a newly devised and validated measure of footcare function (NAFF) which was also delivered by post. All outcomes were assessed by researchers blind to allocation group. Mean age was 64.9 (SD 10.9) years, and there were no differences between groups at baseline in terms of demographics, diabetes type and complications. The incidence (%) of new ulcers at 6 and 12 months was 26 (30%) and 36 (41%) in the intervention group and 18 (21%) and 35 (41%) in the controls, RR 0.997 (CI 0.776-1.280). There were no differences in any of the other outcome measures although the intervention group reported a higher score in recommended foot care behaviour when compared with controls (42.0 versus 38.7, p=0.03).
- Conditions
- Foot Ulceration in Diabetes
- Being tested
- Education
- Keywords
- Diabetes, Education, Ulcer, Foot, Behaviour
- Medical subject headings
- Diabetes Mellitus, Ulcer, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Other | Patients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer recurrence.
Measured: 6 and 12 months
Secondary outcomes (1)
Amputation. Quality of life. Mood. Well-being. Compliance.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startApr 2003
- Primary completionApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot Ulceration in DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Investigators
- William J Jeffcoate, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729456
- Sponsor's protocol ID
- 02ME06
- Acronym
- ESP
- Status last verified
- Jul 2008
- First submitted
- 4 Aug 2008
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia. 2008 Nov;51(11):1954-61. doi: 10.1007/s00125-008-1110-0. Epub 2008 Aug 30.
PubMed 18758747
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Education in the Secondary Prevention of Foot Ulceration in Diabetes
- ClinicalTrials.gov ID
- NCT00729456
- Acronym / sponsor ID
- ESP / 02ME06
- Conditions
- Foot Ulceration in Diabetes
- Keywords
- Diabetes, Education, Ulcer, Foot, Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- Apr 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Aug 2008 (estimated)
- 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.
This study was an attempt to confirm the results of an earlier experiment in which the benefit of an education programme was assessed in a group of people with diabetes complicated by ulceration of the foot. Foot ulcers are the source of considerable suffering and cost and carry a high risk of amputation: they are difficult to heal and approximately 40% recur in the first 12 months. The earlier experiment (published by Malone and colleagues in 1989) indicated that a single hour-long education session appeared to lead to a three-fold reduction in the numbers of ulcers which recurred after successful treatment. It was not possible to confirm these findings in the present study in which patients from three specialist clinics in Nottingham and Derby, UK, were allocated either to receive a one-to-one, individually targeted, education programme in the own home (and reinforced after one month by a telephone call), or to receive usual care. The group who received the education reported better recommended foot care behaviour (intended to minimise the risk of injury) at 12 months but despite this, there was no difference between the two groups in the percentage who suffered either a new ulcer (41% education versus 41% usual care) or amputation (10% and 11%, respectively). While the benefit of education is undeniable in general, it was not possible to show that this particular teaching session had an impact on the occurrence of new disease in this group of patients.
Detailed description
This was a randomised controlled trial of the effect over 12 months of a one-to-one educational package designed to improve foot care behaviour in a group of patients at the highest risk of new foot disease: those with a recently healed ulcer. The primary outcome was the incidence of new ulceration at 12 months. Secondary outcomes included self-reported footcare behaviour, new ulceration at 6 months, amputation (major or minor) at 12 and 6 months, and measures of well-being (SF36; Diabetic Foot Ulcer Scale, DFS short-form). The educational intervention was based on the content of the International Consensus on the Diabetic Foot, 2003, was modified following discussion with a focus group of former ulcer sufferers, and included graphic images of different forms of foot disease. Although structured, the information was targeted in discussion to the individual's circumstances, and was delivered one-to-one in the patient's own home by a single health care professional. It was reinforced after one month by a semi-structured phone conversation with the same educator. Outcomes were determined by postal questionnaire, backed up with reminders and phone calls when necessary, as well questionnaires sent to GP staff and by searching hospital records. Foot care behaviour was assessed at 12 months using a newly devised and validated measure of footcare function (NAFF) which was also delivered by post. All outcomes were assessed by researchers blind to allocation group. Mean age was 64.9 (SD 10.9) years, and there were no differences between groups at baseline in terms of demographics, diabetes type and complications. The incidence (%) of new ulcers at 6 and 12 months was 26 (30%) and 36 (41%) in the intervention group and 18 (21%) and 35 (41%) in the controls, RR 0.997 (CI 0.776-1.280). There were no differences in any of the other outcome measures although the intervention group reported a higher score in recommended foot care behaviour when compared with controls (42.0 versus 38.7, p=0.03).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Other | Other: EducationPatients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diabetes and an ulcer of the foot which had been managed at one of the three participating centres and which had healed within the preceding 3 months, leaving them ulcer-free for at least 28 days
Key exclusion criteria (6 listed)
- Living in institutional care
- Documented history of dementia
- Other serious medical problems
- Non-English speaking and without an English-speaking carer
- Lived more than 50 miles from the centre
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 |
|---|---|---|
| EducationPatients receive a single session, one-to-one workshop (carers may be included if appropriate) in their own home, lasting 60 - 120 minutes. | Other | 2 |
Primary outcome
Ulcer recurrence.
Time frame: 6 and 12 months
1 secondary outcome
Amputation. Quality of life. Mood. Well-being. Compliance.
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
- Derived from this study: PubMed 18758747Lincoln NB, Radford KA, Game FL, Jeffcoate WJ. Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial. Diabetologia. 2008 Nov;51(11):1954-61. doi: 10.1007/s00125-008-1110-0. Epub 2008 Aug 30.
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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.
William J Jeffcoate principal investigator
Nottingham University Hospitals NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Foot Ulceration in Diabetes, run by Nottingham University Hospitals NHS Trust at 3 sites in United Kingdom.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer recurrence. (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729456, which also lists 1 linked publication.
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 7 Aug 2008.